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[IPp] Attention Paradigm users

Someone mentioned going to the diabetesnet.com site to check out a slide
show on the pump by John Walsh.  While on that site, I checked out their
comparason chart of the different pumps.  My son uses the Animas pump, but a
friend of mine just got a Paradigm for her daughter (her doctor would only
use Minimed). When looking at the Paradigm, then looking further into it's
programing issues, I found these statements (which I'm copying and pasting
from the site).  You may or may not know of these precautions.  Just in
case,  please read the following:

Despite high expectations, safety issues have arisen with this pump that
users and clinicians should be aware of. Clinicians were surprised at the
number of safety issues from a 20 year old pump company. The Paradigm is
able to deliver excellent blood sugar control, but the wearer must keep the
issues below in mind to prevent problems.

Programming Issues

Loss Of Basal Rates

Software improvements were introduced in September, 2002, after users
reported that basal rates they would vanish during battery changes and at
other times. During battery changes or while retracting the driver, basal
rates would zero out with only a "Reprogram" alarm or loss of clock time.
Several cases of ketoacidosis were reported because of this. Nonvolatile
memory should allow a battery to be removed for years without losing basal
rates or history. For unclear reasons, the Paradigm has had trouble
retaining basals.

Medtronic says their new pumps "will include updated software that will
allow the pumps to be shipped and stored without batteries" but adds "We
want to reinforce that current Paradigm pump users do not need to return
their pumps." Our suggestion is that if you encounter a loss of basal rates
you request an immediate replacement for the newer version. Non-delivery
should never occur in any medical device that delivers a life-sustaining

When basal rates are lost, the Paradigm cannot give a specific warning that
a loss of basal rates has occurred. An alarm will sound because of the loss
of the clock setting. The pump displays a reprogram alert in older versions
and "Check Settings" in newer Paradigms. When the alarm sounds, the user
must be aware to check to ensure that their basal profiles may have been
erased. Wearers are advised to keep a copy of their current basal rates
handy at all times. This problem is rarely encountered in other brands.
Nonvolatile memory should prevent this problem.

Do Not Choose U-50 Insulin By Accident

Software has improved in the Paradigm, but one change can be dangerous for
the unaware. In contrast to other pumps and previous MiniMeds, selecting the
insulin concentration was moved from the utilities area to the prime screen.
This move means that every two or three days, when someone goes to prime
their infusion line, one of the first screens they encounter asks them to
choose whether they want U-100 or U-50 as their insulin concentration.

Ordinarily, this is a trivial issue as the default U-100 is selected on the
prime screen, but let's say a pumper is a little low, a little overweight,
or a little unaware one day as they prime their pump. They may think they'd
like less insulin and a weaker U-50 variety might help them. So they select
U-50 and agree to the confirmation screen, but fail to change the insulin in
their pump to the weaker U-50 variety. Their pump now thinks it is
delivering diluted insulin that has a strength half that found in the
insulin vial.

In this situation, the Paradigm immediately doubles all insulin delivery!
Someone who uses 40 units a day will suddenly receive 80 units. Read one
child's experience with this. The child's parents are advised not to allow a
10 year old to change their own infusion set, but a child should not
encounter this danger and would not with any other pump. The unneeded U-50
option should be placed back in the remote corner of the utilities area
where pumpers rarely go.

Be Careful Not To Clear Pump

In the utilities section, one new option is called "clear pump". It means
exactly that---all basals and history are erased when this option is
selected and agreed to. It was placed into the pump at the request of sales
reps and pump trainers, but can create problems for the unaware.

This option is generally a small risk, but a teen may decide this is a
wonderful way to erase the sizes of or incompleteness of their boluses. It
can prove annoying to a user who thinks it is a good way to silence an
alarm, or to someone who accidentally wanders into pressing the wrong
sequence of buttons because they are not paying attention. Once cleared, an
alarm will warn that the clock setting has been lost, but again no notice is
given that the basals were also erased.


Do Not Retighten Dislodged Reservoir Caps Before Disconnecting

The plastic reservoir in the Paradigm is smaller. During loading, the
reservoir is dropped down into the pump. Improvements to the reservoir
design make it easier to load and makes it easier to eliminate bubbles. A
multipurpose cap built into the infusion line seals the reservoir into the
pump, and provides the connection for the infusion line and also vents the

Danger arises, however, from the design of the multipurpose cap. This cap
locks the reservoir in place with a half turn, but only a small indentation
in the plastic at the end of its threading prevents the cap from coming
undone. If it becomes dislodged, such as when it is fiddled with (i.e., by
children) or hit by a glancing blow from an object in the pocket, insulin
delivery stops. There is no alarm to alert the user that this has happened.

High blood sugar or ketoacidosis can result, but the pumper may encounter
another problem as well. When a high blood sugar is discovered and the pump
is checked, the cap to the reservoir may be found to be ajar. Most pumpers
will retighten the hub when they see this. In other pumps this was not
especially dangerous because very little insulin would be delivered when the
hub is retightened.

However, the Paradigm is not like other pumps. When its cap comes loose, the
reservoir has nothing to keep it in place and will float on top of the
advancing driver. The coarse threading in the cap allows it to be tightened
with a half turn, but this also creates a large movement of the plunger as
the cap is retightened. A twist of the cap at this point can deliver all of
the insulin that was not delivered while the cap was loose. Doses as large
as 15 to 20 units can be delivered, depending on how long the problem went
unnoticed. An unaware user may not realize this large unintentional bolus
was given and proceed to give an additional correction bolus for the high
blood sugar. The combined intentional and unintentional boluses may result
in an extremely low blood sugar.

Paradigm users must be aware never to retighten a loose reservoir cap until
they have disconnected from their infusion line. Children and active adults
should not fiddle with this connection. MiniMed suggests that users always
keep their pump in its protective cover to prevent this type of detachment.

The hub design may not fully comply with International Standards for Medical
Electrical Equipment (IEC 60601-2-24, section 54.101). Under "Fitting of the
Syringe" for infusion pumps, the standard reads "means shall be provided to
ensure correct clamping and location of a syringe barrel." This standard was
developed by experts in the field to avoid overdelivery when reservoirs are

A Smaller Reservoir If You Need More Than 52 Units A Day

Unlike the Cozmo, Diabecare II, and two other small pump that are expected
early in 2003, which all have 300 unit or larger reservoirs, the Paradigm's
small size was achieved partly by reducing the reservoir size. Fully loaded,
it holds 176 units of insulin leaving 156 units after filling a 43 inch
infusion line. Pumpers who use less than 52 units a day can continue to
change their reservoirs every three days, while those that use 52 to 78
units will need to start changing every other day, and those requiring over
78 units a day will need to change daily to avoid running out of insulin.
For convenience and to reduce costs, MiniMed recommends pumpers who use more
than 50 units a day use the 508 insulin pump.

O-ring leaks occur even with today's reservoirs. This reservoir came from a
64 year old woman who arrived at a clinic one morning with a 364 mg/dl blood
sugar. Usually in excellent control (70 to 120 mg/dl before meals) and
normal the night before, she had experienced several unexplained high
readings in the previous weeks. The prior week she had nausea with positive
ketones and a blood sugar over 450, very likely from the same cause. That
high reading was corrected after two syringe injections.

When one reservoir in a box goes bad, replace the entire box of reservoirs.
Made from the same mold, others with the same lot number are also very
likely to leak. O-ring leaks are hard to detect. Only after the plastic
labeling was removed and the reservoir wall had been cleaned with alcohol
could the leak above be clearly observed. (She has not encountered
unexplained highs since starting a new lot of reservoirs.)

Users who need more than 50 units may experience a dramatic rise in their
annual expense for infusion sets and reservoirs. Annual costs for those who
use less than 52 units a day and change every three days (close to 75% of
all pumpers,) will remain at about $1,715.50 a year. Those on 52 to 78 units
a day would increase to $2,573.25 a year (Teflon sets at $11 apiece and
reservoirs an additional $3.10), while those using over 78 units a day
(roughly 5% of Type 1s and 40% of Type 2s) could start ringing up $5,146.50
a year if they were to replace both reservoirs and infusion sets (price does
not include insulin or adhesives). Users, of course, may want to replace
only the reservoir each day and leave their infusion set in place
(disconnecting during replacement, of course) to reduce costs.

Improved Motor Technology

Like the DC motors in other pumps, the Paradigm motor is stronger than the
solenoid motor in the 500 series pumps. In contrast to the push mechanism of
DC motors which are able to deliver any amount of insulin, the solenoid
motors of the 506, 507 and 508 pumps work via a pull mechanism that can
deliver only a fixed amount of insulin.

In spite of its DC motor, the Paradigm delivers only a fixed 0.1 unit of
insulin at a time. Although the company has trademarked this packet delivery
as "exclusive BioPULSE delivery", BioPULSE has no advantage that we are
aware of. Other pump companies have chosen to offer timed delivery rather
than dosed delivery. In other words, they reduce how much insulin is
delivered so that it can be delivered every 3 or 4 minutes. MiniMed chose to
stay with a set dose of 0.1 units that is given at whatever time interval is
required to deliver a certain basal rate. Physiologically, neither approach
is likely to make any significant difference in blood sugar control.

For unknown reasons, MiniMed decided not to offer 0.05 unit basal increments
with the Paradigm, although this is available in the existing Animas pump
and two upcoming pumps. The Paradigm motor was designed to deliver U-200
insulin, so a simple software change would allow it to deliver 0.05 unit
basal increments. Finer basal adjustment can be a real help to those who use
less than 25 to 30 units of insulin a day.

The motor is powered by a single AAA battery that is easy to find, although
the remote requires a harder-to-find A23 battery. MiniMed recommends only
one brand of batteries (Energizer) because they last 2 to 3 weeks, and
occasionally 4 weeks for energy conservationists. Use of features, such as
the remote and backlight, shorten battery life. Other battery brands may
last only 1 to 2 weeks. Rechargeable batteries are discouraged. Some users
may prefer this option, but it is prudent to use the longest-lived battery
available to reduce the chance of losing the basal rates during battery
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