inforMED
InjuryLZG

TANDEM X2 INSULIN PUMP

Received Dec 18, 2023 · Event occurred Dec 9, 2013

Report MW5149360 · MDR key 18358169

Device

Generic name

Pump, Infusion, Insulin

Patient

57 YR · Male

  • Hyperglycemia
  • Hypoglycemia
  • Pain
  • Hyperglycemia
  • Hypoglycemia
  • Pain

Narrative

Description of Event or Problem

I AM A TYPE 1 DIABETIC THAT USES AN INSULIN PUMP. TANDEM DIABETES SENT A NOTICE SAYING THAT I COULD UPGRADE TO THE NEW DEXCOM G7 IF I UPDATED THE SOFTWARE ON THE PUMP. THE UPDATE CAUSED MY CURRENT G6 CMG TO MALFUNCTION AND NO LONGER WORK. MY PUMP DOES NOT FUNCTION CORRECTLY WITHOUT THE CGM BECAUSE IT'S A CLOSED LOOK SYSTEM. NOW I HAD TO REVERT TO FINGER STICKS TO CHECK MY SUGAR HOWEVER THE PUMP USES A SYSTEM THAT MONITORS YOUR BG (BLOOD SUGAR) TO BE ABLE TO INCREASE OR DECREASE INSULIN DELIVERY BASED ON YOUR BG. WITHOUT THAT SYSTEM FUNCTIONING IT LEADS TO HIGH AND LOW BG'S THAT CAUSE PAIN AND SUFFERING. THEN 2 DAYS LATER I GET THE NEW DEXCOM G7 FROM THE PHARMACY. I INSERTED AND TRIED TO START THE NEW G7 SENSOR ONLY TO IMMEDIATELY RECEIVE AND ERROR STATING THAT MY PUMP IS NOT COMPATIBLE WITH THE NEW G7. I CALLED AND SPOKE TO TANDEM AND WAS TOLD ABOUT THE COMPATIBILITY ISSUES WITH CERTAIN DEXCOM G7 CGM'S. THIS IS NOT A DEXCOM ISSUE BECAUSE THEIR G7'S WORK WITH OTHERS PUMPS THAN THE TANDEM X2. NOW I HAVE TO CONTINUE TO SUFFER BECAUSE TANDEM DROPPED THE BALL AND FAILED TO DO TESTING THAT WOULD HAVE RESOLVED THIS ISSUE SO THAT THE CONSUMERS WOULD NOT HAVE TO SUFFER. I THEN NOTIFIED THE PHARMACY OF THE COMPATIBILITY ISSUES WITH THE DEXCOM G7 WHEN USED WITH THE TANDEM PUMP. THE PHARMACIST I SPOKE TO WAS COMPLETELY UNAWARE OF THE ISSUE. THAT MEANS THAT TANDEM FAILED TO NOTIFY THE MEDICAL SUPPLY LOCATIONS THAT THE CONSUMERS GET THEIR SUPPLIES FROM. TANDEM COMPLETELY FAILED ME. YES TANDEM WAS AWARE OF THE ISSUES WITH THEIR PUMP NOT BEING COMPATIBLE WITH CERTAIN DEXCOM G7 CGM'S WHICH COULD HAVE BEEN RESOLVED BEFORE THE RELEASE OF THE SOFTWARE UPDATE BUT DIDN'T FIX THE PROBLEM.