BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM X2

    MDR report key: 19212073 · Received April 26, 2024

    Report

    Report Number
    MW5154412
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 24, 2024
    Report Date
    April 24, 2024
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TANDEM T:SLIM X2 INSULIN PUMP WITH CONTROL IQ IS SUPPOSED TO CONNECT WITH DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (CGM) AND ADJUST INSULIN DELIVERY BASED ON GLUCOSE READINGS. WHEN I WEAR THE DEXCOM G7 ON THE BACK OF MY ARM (THE ONLY LOCATION APPROVED FOR WEAR) AND MY INSULIN PUMP IS IN A LOOSE POCKET ON THE OPPOSITE SIDE OF MY BODY (E.G., IN RUNNING SHORTS OR PAJAMA PANTS), THE INSULIN PUMP LOSES ITS CONNECTION TO THE DEXCOM - SIMPLY BECAUSE MY BODY IS IN THE WAY. IN OTHER WORDS, IT'S WITHIN 3 FEET OF THE INSULIN PUMP AND STILL CAN'T READ THE CGM READINGS. THEREFORE, IT CANNOT WORK AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172759 TANDEM T:SLIM X2 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC. 001002717

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other DEXCOM G7 CONTINUOUS GLUCOSE MONITOR (CGM).| ESTRADIOL.| HYDROCHLOROTHIAZIDE.| LISINOPRIL.| NOVOLOG INSULIN.| PROGESTERONE.| SIMVASTATIN.