inforMED
InjuryQFG

TANDEM MOBI INSULIN PUMP

Received Jul 16, 2026

Report MW5190778 · MDR key 25839647

Device

Generic name

Alternate Controller Enabled Insulin Infusion Pump

Product problems

  • No Audible Alarm
  • No Flow

Patient

39 YR · Female

  • Hyperglycemia

Narrative

Description of Event or Problem

TANDEM MOBI INSULIN PUMP MALFUNCTIONED AND WAS REPLACED TWICE. WITH THE THIRD MOBI I WOKE UP ON MY OWN TO BG ALMOST 400 AND ISSUE 1 NO ALARM WOKE ME UP. THE MOBI ALARM WAS EITHER NOT LOUD ENOUGH OR IT HAD NOT GONE OFF AT ALL AND ISSUE 2 FOR WHATEVER REASON, I WAS NOT GETTING INSULIN. EITHER THE PUMP STOPPED GIVING IT OR IT WASN'T GIVING ENOUGH. I CHANGED MY SITE MULTIPLE TIMES, BOLUSED WITH PUMP MULTIPLE TIMES AND BG STILL DID NOT GO DOWN UNTIL I GAVE MYSELF A MANUAL BOLUS. I'VE NEVER HAD SEVERE ISSUES LIKE THIS WITH THE TSLIM X2 AND IT HAD NEVER NEEDED REPLACED IN THE 5 YEARS I HAD IT. I BELIEVE THIS DEVICE IS NOT MADE WELL OR DEFECTIVE AND UNSAFE. TANDEM HAD DOCUMENTATION ON WHY TWO PUMPS NEEDED REPLACED AND MY DR (B)(6) WOULD HAVE DOCUMENTATION ON WHEN MY BG RAN HIGH AND ALL THE BOLUSES I TOOK TO TRY TO GET IT DOWN, AND ALL THE SITE CHANGES WHICH DID NOT HELP LOWER MY BG EITHER. PT: 1905. DEVICE: 1019, 2991. REF: MW5190776, MW5190777. THIS REPORT CAPTURES TANDEM MOBI INSULIN PUMP #3.