BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 WITH INTEROPERABLE TECHNOLOGY: DEN180058

    MDR report key: 14251179 · Received April 29, 2022

    Report

    Report Number
    3013756811-2022-47777
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 13, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE PATIENT LINE. CUSTOMER'S BLOOD GLUCOSE WAS APPROXIMATELY 400 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99537 T:SLIM X2 WITH INTEROPERABLE TECHNOLOGY: DEN180058 ALTERNATE CONTROLLER ENABLED INFUSION PUMP LZG TANDEM DIABETES CARE W0228797

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown