BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 9378933 · Received November 26, 2019

    Report

    Report Number
    3013756811-2019-85630
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 12, 2019
    Report Date
    November 26, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004538
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THERE WAS A PIECE OF THE CARTRIDGE MISSING. A NEW CARTRIDGE WAS SUCCESSFULLY LOADED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED. BLOOD GLUCOSE WAS 140-210 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172629 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M015546 00852162004538

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR