BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11929725 · Received June 3, 2021

    Report

    Report Number
    3013756811-2021-57998
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 16, 2021
    Report Date
    June 3, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007257
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 A MALFUNCTION ALARM OCCURRED. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 200-426 MG/DL. REPORTEDLY, THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS ELEVATED BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827957 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other