FDA Adverse Event Injury Summary report: N

TANDEM MOBI

MDR report key: 22106289 · Received May 29, 2025

Report

Report Number
MW5170881
Event Type
Injury
Date Received
May 29, 2025
Date of Event
March 1, 2024
Report Date
May 21, 2025
Manufacturer
TANDEM DIABETES CARE INC.
Product Code
QFG
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER
Health Professional
*

Narratives

Description of Event or Problem · 0

TANDEM DIABETES CARE INC. RELEASED THE MOBI. I CANNOT BEGIN TO TELL YOU HOW MANY PEOPLE HAVE BEEN HOSPITALIZED DUE TO HOW TERRIBLY ENGINEERED THE PRODUCT IS. THE PISTON THAT ACTS AS THE PUMPING MECHANISM TO PUSH INSULIN THROUGH THE INFUSION SET BREAKS VERY EASILY. IT'LL THEN ALARM THE USER TO SEVERAL OCCLUSIONS BEFORE FINALLY ALARMING CARTRIDGE ALARMS. THESE CARTRIDGE ALARMS MEAN THE PISTON IS STUCK AND WILL NOT DISPENSE ANYMORE INSULIN. THERE DOESN'T SEEM TO BE A COMMON DENOMINATOR OF WHAT CAUSES THIS ASIDE FROM MULTIPLE OCCLUSIONS, THE USERS THEMSELVES, AND THE CARTRIDGE ALARMS. THE TROUBLESHOOTING PROVIDED IS OFTEN GIVEN TOO LATE BECAUSE PTS WILL OFTEN NOT PHONE IN TO TANDEM DIABETES CARE. I'VE HEARD MANY STORIES WHERE PATIENTS WILL ONLY CALL ONCE THE ALARMING, THE BEEPING, THE CONSTANT WASTE OF INSULIN, AND SUPPLIES, BRINGS THESE USERS TO A BREAKING POINT. THE MOBI WILL ALARM WITH SEVERAL OCCLUSIONS AND WILL NOT ALLOW A PATIENT TO BOLUS. THE PATIENT IS FORCED TO CHANGE OUT SUPPLIES ENTIRELY BUT SOMETIMES THAT DOESN'T EVEN WORK. SEVERAL PATIENTS RELY ON THE MOBI AND THE CONTROL-IQ ALGORITHM TO KEEP THEM FROM CRASHING LATE AT NIGHT AND PERHAPS DYING. I CAN ONLY IMAGINE SEVERAL PEOPLE HAVE DIED BECAUSE OF THIS PUMP FAILURE YET I BET IT DOESN'T GET REPORTED BECAUSE, REALLY, WHAT'S THE ACTUAL CAUSE OF DEATH? EITHER DIABETIC KETOACIDOSIS (DKA) OR SEIZURES FROM AN INCREDIBLY LOW BLOOD GLUCOSE. BOTH THINGS THE MOBI IS SUPPOSED TO PREVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
36252 TANDEM MOBI ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention| S| L| H