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FDA > CDRH > Medical Device Recalls > Class I Recall - Disetronic D-TRON Insulin Infusion Pump

Medical Device Recalls
Class I Recall: Disetronic D-TRON Insulin Infusion Pump

Date Recall
Initiated
 June 17, 2002
Product:
 Disetronic D-TRON Insulin Infusion Pump,
Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthracite)
Use:
 The D-TRON Insulin Infusion Pump is used for patients with insulin dependent diabetes mellitus who do not have good blood glucose control with conventional insulin injections. Patients on insulin pump therapy must perform self-monitoring of their blood glucose levels on a regular basis.
Recalling Firm:
 Disetronic Medical Systems, Inc.
5151 Program Avenue
St. Paul, MN 55112-1014
Reason for Recall:
 Some pumps started programming a bolus of insulin that was not initiated by the pump user and the delivery of an unintended bolus was made unless it was stopped by the device user.
Firm
Official :
 David E. Chadwick, PhD.
Official: Director, Regulatory Affairs/Quality Assurance
763-795-5277
FDA District:
 Minneapolis, MN
FDA Comment:
 FDA considers that the probability of life threatening consequences is possible by use of this model pump.
  For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2003/ENF00791.html. Scroll down to “Recalls and Field Corrections: Devices – Class I”.

Updated May 6, 2003

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