BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7035043 · Received November 15, 2017

    Report

    Report Number
    3007981285-2017-33543
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 15, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE CUSTOMER RECEIVED AN INACCURATE FILL ESTIMATE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 300 UNITS, AND DISPLAYED A FILL ESTIMATE OF 105 UNITS AFTER DELIVERING 62 UNITS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 140-192 MG/DL. REPORTEDLY, THE CUSTOMER RELOADED THE SAME CARTRIDGE SUCCESSFULLY AND RECEIVED AN ACCURATE FILL ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812775 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR