BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22308401 · Received June 23, 2025

    Report

    Report Number
    3013756811-2025-151366
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    March 1, 2024
    Report Date
    June 23, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MDR REPORT # MW5170881.

    Description of Event or Problem · 0

    VOLUNTARY MEDWATCH RECEIVED REPORTED: 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
    755851 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male TANDEM - CARTRIDGE| UNKNOWN - INSULIN| UNOMEDICAL - INFUSION SET