BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10194660 · Received June 25, 2020

    Report

    Report Number
    3013756811-2020-62891
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 25, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613212
    PMA / PMN Number
    DEN180058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL RANGING FROM 220-600 MG/DL CAUSE WAS UNKNOWN. BG WAS ADDRESSED VIA A CORRECTION BOLUS, AND MANUAL INJECTIONS. TANDEM TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER, HOWEVER, NO RESPONSE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658483 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613212

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other