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 Insulin
Infusion Pump Recall
On July 13, 2006, the FDA assigned a Class I
recall for Disetronic D-TRONplus Insulin Infusion
Power Packs. Reference numbers BAT04697014001
and BAT3000813.
The pumps are used for continuous delivery of
insulin for the treatment of insulin-dependent
diabetes mellitus. The power packs provide power
to the D-TRONplus pumps. The power packs have
the potential to shut down without warning. This
could mean that the pump would not have sufficient
notice to recognize the power supply decrease
and therefore would not give the audible warning
to notify the patient of the problem. In the
end, insulin delivery could be interrupted leading
to elevated blood glucose levels, diabetic ketoacidosis
and even death.
Disetronic Medical Systems notified patients
and their physicians of the problem via an urgent
product recall on July 13, 2006. The company
has stated that patients must insert a new power
pack into their pump every two weeks to prevent
the pump from turning off without warning. Patients
who experience hyperglycemia should check their
blood glucose levels.
Please contact us for more information regarding
the use of insulin pumps and diabetes mellitus.
For a case of this nature, we can provide the
following list of services:
- Medical Chart Review
- Medical Chronology Report
- Expert Witness Identification and
Location
Reference
U.S. Food and Drug Administration; Center for
Devices and Radiological Health Class I Recall:
Disetronic D-TRONplus Insulin Infusion Pump
Power Packs (2006). Retrieved October 2006
from www.fda.gov/cdrh/recalls/recall-071306html.
For more information on this issue please
see Contact Us
and see how our services can work for you.
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