BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7105285 · Received December 11, 2017

    Report

    Report Number
    3007981285-2017-38079
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 11, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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 MULTIPLE CARTRIDGES LEAKED FROM THE BOTTOM OF THE CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-337 MG/DL. A NEW CARTRIDGE WAS SUCCESSFULLY LOADED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885792 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR