BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13259000 · Received January 14, 2022

    Report

    Report Number
    3013756811-2022-01407
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 14, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    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 A MALFUNCTION ALARM OCCURRED AND THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 143 - 166 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER RESET THE PUMP AND CORRECTED THE TIME AND RESUMED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626129 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female