BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 10863869 · Received November 18, 2020

    Report

    Report Number
    3013756811-2020-127058
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 18, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613786
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP RESET UNEXPECTEDLY. IN ADDITION, THE PUMP WAS HOT TO THE TOUCH WHILE PLUGGED IN AND CHARGING. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS BETWEEN 130-131 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328445 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613786

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR