BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15567633 · Received October 7, 2022

    Report

    Report Number
    3013756811-2022-106844
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 14, 2022
    Report Date
    November 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. H3, H10. ADD MDR CODES 11, 3233, 4118. REMOVE CODES 3221, 4114, 67.H3, H10. ADD MDR CODES 11, 3233, 4118. REMOVE CODES 3221, 4114, 67.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. THE PUMP'S DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 110 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2898008 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male