BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 9944025 · Received April 9, 2020

    Report

    Report Number
    3013756811-2020-34147
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    March 17, 2020
    Report Date
    April 9, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00852162004781
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: YOU SHOULD AVOID ACTIVITIES WHICH COULD EXPOSE YOUR PUMP TO TEMPERATURES BELOW 41ºF (5ºC) OR ABOVE 98.6ºF (37ºC), AS INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS IN A COOLER WITH A TEMPERATURE OF 40 DEGREES, AND THE TOUCHSCREEN SUBSEQUENTLY BECAME UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120-174 MG/DL. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407118 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR