BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 18796785 · Received February 28, 2024

    Report

    Report Number
    3013756811-2024-30393
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    January 28, 2024
    Report Date
    February 28, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED INTERMITTENT, ON-GOING ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGING BETWEEN 501-1000 MG/DL. CAUSE WAS NOT KNOWN. REPORTEDLY, DUE TO THE ELEVATED BG LEVELS, THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2024. CUSTOMER REVERTED TO AN ALTERNATE FORM OF INSULIN THERAPY. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497741 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female