Tandum Diabetes Care is recalling roughly 47,460 t:cell insulin cartridges that may leak, potentially causing the wrong dose of insulin to be administered, which could place diabetics at risk of serious adverse health consequences.
The Tandem t:call insulin cartridge recall was announced by the FDA on January 10, after internal product testing confirmed the cartridges may leak.
As a result of this problem, the cartridge may cause too much or too little insulin to be delivered to users.
Although Tandem indicates that it has not received any reports of injuries in connection with the recalled t:cell cartridges, an imbalance of insulin may cause diabetics to suffer life-threatening hypoglycemia, or diabetic shock, which is a serious condition caused by too much or too little insulin. This could lead to the individual going into a coma or result in death.
The insulin cartridge recall consists of Tandem Diabetes Care Insulin cartridges used with the t:slim Insulin Pump. The affected cartridges were packaged in boxes of ten and shipped on or after December 17, 2013. For a full list of recalled lot numbers customers may visit http://www.fda.gov/Safety/Recalls/ucm381473.htm.
President and CEO of Tandem Diabetes Care announced the problem causing the cartridge leak had been identified and a manufacturing change has already been implemented to prevent any further affected cartridges.
Tandem advises users to check their existing inventory to confirm if any remaining products are part of the recall and stop using them immediately. Customers should contact Tandem Technical Support at 1-877-801-6901 to receive free replacement cartridges in a timely manner.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to these products by completing the form on the MedWatch adverse event reporting site or by calling 1-800-332-1088.