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Pump Manufacturers:
Animas - Deltec - Disetronic - Lifescan - MiniMed - Dana 

Loss Of Basal Rates
Do Not Choose U-50
Careful Of Clear Pump
Disconnect Before Retightening The Cap
A Small Reservoir
508 Pump

 Medtronic MiniMed's Paradigm 512 and 712 Insulin Pumps replace the Paradigm 511
model which had major problems due to loss of basal rates and history when the
battery was removed or when it came in contact with static electricity. Wiring
and soldering are said to be improved in the current model with better
electronic protection. The battery can now be taken out for 30 to 40 minutes
before the pump loses its time setting. Basal rates are said to be protected for
about a month. Medtronic charges $450 (recently discounted to $299) for users of
the defective 511 to upgrade.

 The reservoir in the 512, released in July, 2003, holds 176 units, while that
in the 712 holds 300 units in a snubnose pump format. Both connect via radiowave
to Becton Dickinson's Logic meter, pictured on the left. The meter requires 0.3
ul of blood with results in 5 seconds. The accuracy of the meter appears to be
good, but some users have noted an excess number or errors during testing.
Results are sent to the Paradigm for an estimated correction dose based on the
user's selected correction factor. The user can take the suggested correction
dose or enter their own. The pump records meter readings, daily doses, and
timing. It is not known how much cell phone or radio traffic may interfere with
the radio contact between the two units during a test. The radio wave broadcast
range is small, so testing on a plane should not be a problem.

 Sold separately with a cable is BD's Solutions Software for data presentation
on the PC. Medtronic's online store sells only BD test strips ($0.86 each).
Those who prefer to continue using other strips may want to try Logimedix or
Advanced Diabetes Supplies if you have insurance, or our store if you do not.

 When the 511's remote unit was activated, the pump would search throughout the
day for the remote's messages. This searching cut battery life in half, with
users getting only one to two weeks of use per battery. The 512 and 712 corrects
this by having the meter radio its reading to the pump following each test, so
battery life is protected. The remote is no longer included with the pump due to
low usage, and is now sold separately.

 The 512 now delivers basal rates in smaller 0.05 unit increments, a feature
available in other pumps for several years. Bolus increments are still limited
to 0.1 unit steps, compared to 0.025 in the Animas IR1200 and 0.05 in the Cozmo.
Users can set their insulin-to-carb ratio and correction factor, features
originally introduced in the Cozmo pump. A lockout feature is available for
children, as is backlighting. Only Teflon sets are available for the Paradigm's
proprietary connection.

 Safety issues exist that users and clinicians should be aware of. The Paradigm
can deliver good control, but the wearer should keep the issues below in mind to
avoid problems.

Programming Issues
Loss Of Basal Rates

 Software and hardware changes have been made in the 512 and 712 pumps after
users reported that basal rates they would vanish during battery changes or
while retracting the driver in the 511 pumps. Several cases of ketoacidosis were
reported. Basal rates are said to be better protected in the 512.

 If you encounter a loss of basal rates, request that your pump be replaced
until the problem is fixed. Loss of insulin delivery should never occur in a
device that is designed to deliver a life-sustaining medication.

 When basal rates are lost, the warning will not be specific. An alarm,
accompanied by a "Check Settings" screen may appear or the pump may give a
"Reprogram" alarm. When any of these occur, the user should check their basal
profiles to ensure they have not been erased. Wearers are advised to keep a copy
of current basal rates handy with them at all times.

Do Not Choose U-50 Insulin By Accident

 In the 511, selecting the insulin concentration was moved from the utilities
area to the prime screen. This would ordinarily be a trivial issue as the
default U-100 is selected on the prime screen. But if 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

 In this situation, the 511 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 another pump. The unneeded U-50 option was removed in the 512
and 712.

Do Not Clear Pump

 In the utilities section, one option near the bottom is "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 user.

 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 basal rates
were also erased.


A Dislodged Reservoir Cap Can Be Dangerous

 Danger can arise due to the design of the multipurpose cap which holds the
reservoir in place. The cap has coarse threading and is locked in place with a
half turn. Only a small indentation in the plastic cap near the end of the
threading keeps it in place. If the cap becomes dislodged, insulin delivery will
stop with no alarm.

 When a high blood sugar is discovered, a pumper may be tempted to simply
retighten the cap that is found ajar. In other pumps this was not especially
dangerous because very little insulin would be delivered as the Lure lock type
of hub is retightened.

 However, the Paradigm is unlike other pumps. Its reservoir has nothing holding
it in place, so it will float on top of the advancing driver under it. If the
cap is retightened with a half turn while the infusion set is still in place,
all of the insulin that was not delivered while the cap was loose can be
delivered. Doses of 15 to 20 units can be suddenly delivered, depending on how
long the problem went unnoticed. The user may not realize that this large bolus
was just delivered and proceed to give a correction bolus for their high blood
sugar, causing a severe low blood sugar.

 Users must never to retighten a loose reservoir cap on this pump until their
infusion line is disconnected. Children and active adults should not fiddle with
this connection. MiniMed suggests that users always keep the Paradigm pump in
its protective cover to avoid hub detachment.

 International Standards for Medical Electrical Equipment (IEC 60601-2-24,
section 54.101) have warned against floating reservoirs in medical devices.
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 requests that all reservoirs be locked in place so they will not
float on top of the driver and was developed by experts in the field to avoid
unnecessary overdelivery.
 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 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.)


 The MiniMed 508 insulin pump has three different basal profiles similar to
those introduced in the Animas R-1000, a low volume alert, optional vibrate
alert mode, and a "child block" feature to restrict programming. Three basal
profiles allow for different basal needs on weekends, for activity or athletic
events, or for menstruation.

 Like the D-Tron, MiniMed's 508 and earlier 507 pumps have a bi-directional IR
port, although MiniMed's special ComStation, available for about $300, is needed
for downloading, rather than working directly with a computer IR port. The 508
has a remote that lets the user give boluses if the audio is high enough to hear
the dosage delivery or the pump is positioned close to the skin to feel it

 One occasional problem seen with the 508 and earlier MiniMed models is static
electricity, such as that encountered in touching a lawnmower, or a doorknob
after crossing a rug. A static electricity encounter, seen in many "charged"
areas of the country, will erase the pump's current basal rates. The pump should
give an E13 alarm indicating that basal insulin delivery has been terminated.
One warning sign of an electrostatic problem is that the pump clock has also
zeroed out. Basal rates must be checked in these pumps immediately following any
static discharge, and following any unexplained rise in blood sugars or at the
start of any ketoacidosis episode.

 Pumpers first noticed the electrostatic discharge problem by 1987 and has been
seen in 506, 507 and 508 models. A MiniMed web page, no longer available,
recommended that the user remove the pump batteries for six to eight hours and
then reinsert them to remedy the problem. Any serious pump defects or problems
should be reported to the FDA Medical Devices Section.

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