BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 22163426 · Received June 7, 2025

    Report

    Report Number
    3013756811-2025-109663
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 6, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152365510
    PMA / PMN Number
    K233044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE CANISTER. CUSTOMER PRIMED THE TUBING TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250-297 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551064 TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1004000 00389152365510

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female INSULIN TYPE: HUMALOG