BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5994973 · Received October 3, 2016

    Report

    Report Number
    3007981285-2016-12726
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 A CARTRIDGE ALARM 5 OCCURRED DURING THE LOAD PROCESS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 292 MG/DL AND IT WAS ADDRESSED WITH MANUAL INJECTIONS. THE CUSTOMER'S SISTER LOADED A NEW CARTRIDGE AND THE CUSTOMER RESUMED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646552 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M017791

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other INFUSION SET: COMFORT SHORT, INSULIN: NOVOLOG