BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10074215 · Received May 20, 2020

    Report

    Report Number
    3013756811-2020-50520
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 20, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT MALFUNCTION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 240-313 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539381 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR