inforMED
InjuryLZG

TANDEM TSLIM X2 INSULIN PUMP

Received Sep 22, 2025 · Event occurred Sep 8, 2025

Report MW5176344 · MDR key 23122173

Device

Generic name

Pump, Infusion, Insulin

Product problems

  • No Audible Alarm
  • Protective Measures Problem
  • Therapeutic or Diagnostic Output Failure

Patient

58 YR · Female

  • Hyperglycemia
  • Hyperglycemia

Narrative

Description of Event or Problem

I WAS AT WORK AS A PEDIATRICIAN SEEING PATIENTS MONDAY MORNING. SOMEONE BROUGHT IN A SNACK AND WHEN I WENT TO CHECK MY TANDEM TSLIM 2 PUMP FOR MY DEXCOM G7 CONTINOUS GLUCOSE MONITOR BLOOD SUGAR RESULT THERE WAS A MESSAGE ON THE PUMP THAT THE TSLIM HAD MALFUNCTIONED AND WAS NOT WORKING. I DIDN'T KNOW WHEN THAT HAD STARTED AND THERE WAS NO AUDIBLE ALARM TO WARN ME. I CONTINUED TO FINISH MY CLINIC AND THEN RAN HOME TO TRANSFER MY TYPE 1 DIABETES PLAN B WITH A SHOT OF LANTUS AND SHORT ACTING INSULIN SHOTS. I CALLED TANDEM, THE PUMP COMPANY AND THEY SENT ME A REPLACEMENT IN 36 HOURS. UNFORTUNATELY THE NEW PUMP ARRIVED WITH MINIMAL INSTRUCTIONS ON HOW TO START NEW PUMP AND I CONSULTED WITH MY PHYSICIAN TEAM. I'M GLAD I WAS AWAKE WHEN THIS HAPPENED. IT COULD HAVE BEEN CATASTROPHIC IF THE FAILURE OCCURRED OVERNIGHT AND THERE WAS NO AUDIBLE ALARM ABOUT THE MALFUNCTION. I WOULD HAVE BEEN IN DKA IN THE AM. I HAD RECEIVED A NOTICE THAT THE MALFUNCTION MIGHT HAPPEN,BUT IF THEY NEW IT MIGHT HAPPEN THEY SHOULD I REPLACE THE PUMP FOR THE PEOPLE AT RISK. WHEN I GOT HOME THAT AFTERNOON MY BLOOD SUGAR WAS IN THE HIGH RANGE OF 260 FROM THE LACK OF INSULIN FROM SEVERAL HOURS.