Tandem Diabetes Care recalled specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The potential for a cartridge leak was identified during internal product testing. A cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box) and were shipped on or after December 17, 2013. The cause of the potential for cartridge leak has been identified. Modifications to the cartridge manufacturing process have been implemented to prevent this issue from occurring in the future.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication