[Posted 01/14/2014]

AUDIENCE: Endocrinology, Patient, Health Professional

ISSUE: Tandem Diabetes Care announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The affected cartridges may be at risk for leaking. A cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

BACKGROUND: Affected lots were shipped on or after December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

RECOMMENDATION: Customers should discontinue using cartridges labeled with the affected lots. Please see the Firm Press Release for the complete listing. Customers who received affected cartridges are being contacted by the company or its authorized distributors and asked to call Tandem Technical Support to receive replacement cartridges at no charge. Tandem expects to have sufficient quantities of cartridges to replace affected lots in a timely manner. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/10/2014 - Firm Press Release - Tandem Diabetes Care]