Description of Event or Problem · 1
I AM A 17-YEAR USER OF INSULIN PUMPS FOR TYPE 1 DIABETES SWITCHED FROM MEDTRONIC PUMPS TO AN ANIMAS PING PUMP IN (B)(6) 2017. THE PUMP MANUFACTURE DATE IS 08/2016 (S/N (B)(4)). IN (B)(6) 2017 I HAD THREE SEPARATE EPISODES OF DKA AND EXTREME HYPERGLYCEMIA DESPITE MULTIPLE CORRECTION BOLUSES AND INFUSION SET CHANGES; 2 CALLS TO ANIMAS TECHNICAL SUPPORT DID NOT IDENTIFY A PROBLEM. CORRECTION DOSES GIVEN BY TRADITIONAL INJECTION WERE REQUIRED WITH ALL THREE OCCASIONS, AND THE PROBLEM RESOLVED WITH ADD'L SITE CHANGES. ON THE LAST OCCASION, I NOTED INSULIN LEAKING OUT OF THE PUMP BETWEEN THE LUER CONNECTION AND THE RESERVOIR (ANIMAS 2.0 ML, CARTRIDGE, LOT D200363, USE BY 08/01/2018. UNOMEDICAL INSET30 REF 100-396-56, LOT 5153801, USE BY 07/01/2019. THIS WAS DIFFICULT TO DETECT BECAUSE THIS CONNECTION IS HIDDEN FROM VIEW AND COULDN'T BE REPLICATED WITH DISCONNECTING THE DEVICE AND PERFORMING A TEST BOLUS UNLESS YOU ALSO CRIMP/OCCLUDE THE DOWNSTREAM INFUSION SET TUBING. DISCONNECTING THE LUER CONNECTION REVEALED A NEARLY INVISIBLE CRACK IN THE LUER HUB ON THE TUBING END OF THE CONNECTION WHICH IS NOT VISIBLE WHEN THE DEVICE IS ASSEMBLED. I NOTIFIED THE MFR OF THE PUMP, BUT THEY CONSIDER THIS A FAILURE OF THE INFUSION SET WHICH THEY DO NOT MANUFACTURE. I SUSPECT THAT THE FAILURE RESULTS FROM THE ABILITY TO OVER-TORQUE THE CONNECTION BETWEEN THE RESERVOIR AND THE INFUSION TUBING HUB, BUT SINCE THE FAILURE IS IMPOSSIBLE TO DIAGNOSE UNTIL THE PUMP IS ACTUALLY FAILING TO DELIVER LARGE BOLUSES OF INSULIN (SMALL LEAKS ARE IMPOSSIBLE TO SEE BECAUSE OF THE PUMP DESIGN), I HAVE STOPPED PUMP THERAPY FOR THE FIRST TIME IN 17 YEARS WHILE I CONSIDER MY OPTIONS FOR AN ALTERNATE DEVICE DESIGN.