BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11007706 · Received December 15, 2020

    Report

    Report Number
    3013756811-2020-141772
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 14, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WAKE BUTTON WAS STUCK AND COULD NOT BE PRESSED TO ACTIVATE PUMP DISPLAY. ADDITIONALLY, THE CUSTOMER REPORTED THAT THEY EXPERIENCED A RECURRING BUTTON ALARM DUE TO THE STUCK BUTTON. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 180-327 MG/DL. REPORTEDLY, CUSTOMER REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473044 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 14 YR