BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5160540 · Received October 20, 2015

    Report

    Report Number
    3007981285-2015-55484
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 23, 2015
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH ONE CARTRIDGE DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 202 MG/DL. IT WAS CONFIRMED THAT THE CUSTOMER HAD MANUAL INSULIN INJECTIONS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692263 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR