BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6095527 · Received November 11, 2016

    Report

    Report Number
    3007981285-2016-19326
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM 19 WITH A CARTRIDGE DURING BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 80 MG/DL. REPORTEDLY THE CUSTOMER WAS ABLE TO LOAD A CARTRIDGE SUCCESSFULLY, AND RESUME INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747278 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M018187

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR