Tandem Diabetes Care Announces t:slim Cartridge Recall
By Adam Brown
On January 20, Tandem announced an expanded recall on its t:slim insulin pump cartridges – the affected cartridges (listed here) may be at risk of insulin leaking. After the original recall on January 10, Tandem studied other cartridges that might have been affected (looking at cartridges back from when the t:slim launched in August 2012!) and decided to expand the recall to a total of about 12,800 boxes of cartridges, affecting roughly 4,000 patients. Tandem is replacing the cartridges free of charge. The two recall announcements stemmed from a problem in a piece of test equipment identified in Tandem’s own internal testing (not from any patient reports or adverse events).
Impressively, Tandem moved quite quickly to protect patient safety after discovering these issues. Since there have been no patient-reported events, the recall does not seem to be a major problem or threat to t:slim users. Unfortunately, the company had to issue two recall notices, which may affect the public perception of the company even though it acted proactively to assure patient safety. Tandem has corrected the manufacturing test process and company representatives have said they are confident that no other cartridges have been affected. –AB/NL
