BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 20075861 · Received August 27, 2024

    Report

    Report Number
    3013756811-2024-155348
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 27, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K233044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE TUBING DURING THE LOAD FILL PROCESS. REPORTEDLY, THE CARTRIDGE WAS CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE WAS 170-233 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218611 TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000 W1164575

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female