Class 1 Medical Device Recalls - Disetronic/Roche Diagnostics Accu-Chek™ Ultraflex-1 Infusion Set

Date Recall
Initiated:

March 31, 2006

Product:

Disetronic Accu-Chek™ Ultraflex-1 Infusion Set, Catalog # INF04540786001

Use:

For continuous delivery of short-acting or fast-acting U100 insulin for the treatment of insulin-dependent diabetes mellitus.

Recalling Firm:

Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46256-1025

Reason for Recall:

Tubing may fully or partially separate at the luer lock-tubing connection of the pump. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

Public Contact:

Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46256-1025
800-688-4578

FDA District:

Detroit

FDA Comments:

• The company notified patients and their physicians of the problem in letters dated 3/31/06; the FDA subsequently classified this as a Class I recall.
• Customers deciding to continue using the ACCU-CHEK™ Ultraflex or a replacement ACCU-CHEK™ Ultraflex infusion set, must check their infusion set at the luer lock-tubing connection during use at least every 3 hours and before bedtime.   The replacement ACCU-CHEK Ultraflex infusion sets may still experience this full or partial separation of the luer lock-tubing connection.
• Patients experiencing the symptoms of hyperglycemia should check to ensure that their blood glucose level is within an acceptable range. Patients may also contact their physician.
• The symptoms of hyperglycemia include:
  • Nausea/vomiting
  • Blurred vision
  • Excessive thirst or hunger
  • Frequent urination
  • Fatigue/tiredness/sleepiness
  • Headache
  • Fruity acetone breath
  • Abdominal pain

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Consumers with questions may contact the company at 1-(800) 688-4578. A copy of the company’s 4/3/06 press release is available on its Website. http://www.disetronic-usa.com/files/General/Press%20Releases/ACUFXPRFINAL040306.pdf