Tandem Diabetes Care, a diabetes management company, is voluntarily recalling specific lots of insulin cartridges which are used with the t:slim insulin pump after it was found that the affected cartridges may be at risk for leaking.
The company identified the potential problem during its internal product testing.
Till now, the company has not received any complaints or adverse events from the customers regarding the insulin cartridges.
The company, however, determined that a cartridge leak could potentially result in the device delivering too much or too little insulin, which could lead to a serious adverse event.
Tandem Diabetes Care president and CEO Kim Blickenstaff noted the safety of the company’s customers is its top priority, and it is committed to quickly addressing issues if they arise.
"The potential for a cartridge leak was identified during in-house product testing, and the cause has been identified. Modifications to our cartridge manufacturing process have been implemented to prevent this issue from occurring in the future," Blickenstaff added.
The company stated that customers should discontinue using some cartridge lots that were shipped on or after 17 December 2013. All other cartridge lots and the t:slim insulin pump are not affected by this recall.
The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).
Tandem Diabetes Care is providing replacement cartridges to its customers at no additional charge.