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[IPk] [CWDP] Disetronic Recall



I dont know is this effects anyone in the UK

http://www.fda.gov/oc/po/firmrecalls/disetronic07_06.html

Disetronic Medical Systems Inc Announces a Voluntary Nationwide Recall of
Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps
Contact:
Lori LeRoy
317-521-7159



 FOR IMMEDIATE RELEASE -- July 13, 2006 -- Fishers, Indiana -- Disetronic
Medical
Systems Inc. (Disetronic) of Fishers, IN announced today a voluntary nationwide
recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus
Insulin Pump. There is the real potential that the power pack could shut down
the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin
delivery is interrupted. An interruption in insulin delivery may lead to
uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to
serious patient injury and/or death. This is an Urgent Device Correction
notification to health care professionals and their patients not requiring
product removal at this time.
The abrupt shutdown of the D-TRONplus insulin pump is due to a change in the
battery design by its manufacturer. As a result, the pump does not have enough
time to recognize a decrease in the power supply, which causes the pump to shut
down before the audible and vibrating low power alarms are triggered.
 Until further notice all pump users must put a new power pack into their
insulin
 pump every two weeks to prevent their pump from turning off without any
warning.
It is important this two week period not be extended. Disetronic and their
distributors will supply power packs free of charge by UPS next day shipment to
all D-TRONplus users until corrective actions have been implemented. Every user
will receive a power pack together with detailed instructions.
Disetronic and their distributors will also provide every user with a new power
pack every two weeks. Distribution of these power packs will begin on Thursday,
July 13, 2006.
 This is a temporary fix to the power pack problem until adequate supplies of
the
corrected battery can be obtained. We will update all users when the problem is
 resolved. Disetronic has tested the replacement design being shipped and we
have
data to verify a two week use period in the pumps without failure.
If you are a physician or a patient who has experienced a problem with any
Disetronic D-TRONplus Power Packs, please notify Disetronic at 1-800-688-4578.
An interruption in insulin delivery may lead to uncontrolled diabetes mellitus,
resulting in hyperglycemia, which can lead to serious patient injury and/or
death. The symptoms of hyperglycemia may include nausea/vomiting, blurred
vision, excessive thirst or hunger, frequent urination,
fatigue/tiredness/sleepiness, headache, fruity acetone breath, abdominal pain,
and coma. Patients experiencing these symptoms are advised to check their blood
glucose level to ensure that they are within acceptable ranges as defined by
their healthcare team. Patients are advised to contact their health care
provider if they have questions. Users of the D-TRONplus pumps should monitor
 pumps closely to ensure adequate delivery of insulin. Clinicians should
exercise
maximum vigilance in monitoring patients, in the event of any of the
aforementioned signs or symptoms.
Disetronic D-TRONplus Power Packs are available by prescription only for
diabetes patients who use insulin pump therapy. Disetronic is notifying by
direct mail affected customers, healthcare providers and its distributors of
this action.
This recall is being conducted with the knowledge of the U. S. Food and Drug
Administration.
Any adverse reactions or adverse events experienced with the use of this
product, and/or quality problems should also be reported to the FDA's MedWatch
Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at
MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the
MedWatch website at www.fda.gov/medwatch.


Jackie

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