BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T-SLIM PUMP

    MDR report key: 19429516 · Received May 29, 2024

    Report

    Report Number
    MW5155596
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 27, 2024
    Report Date
    May 27, 2024
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TANDEM T-SLIM PUMP CONSTANTLY LOSES CONNECTION TO DEXCOM G7. DEXCOM APP READS THE SENSOR PERFECTLY, BUT THE T-SLIM PUMP LOSE CONNECTION. THIS IS OBVIOUSLY A HARDWARE OR FIRM WARE PROBLEM IN THE PUMP, BUT TANDEM CONTINUES TO DENIES THE PROBLEM. IT IS DANGEROUS, AS THE CONTROL IQ ADMINISTERS TOO MUCH INSULIN WHEN CONNECTION IS LOST.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 6/4/2024 FOR MW5155596 TO UPDATE PROCODE TO QFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148820 TANDEM T-SLIM PUMP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC.
    329815 TANDEM T-SLIM PUMP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male DEXCOM G7.