BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5202322 · Received November 4, 2015

    Report

    Report Number
    3007981285-2015-57634
    Event Type
    Malfunction
    Date Received
    November 4, 2015
    Date of Event
    October 18, 2015
    Report Date
    October 18, 2015
    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WAKE BUTTON HAS STOPPED WORKING. THE DEVICE TURNS ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 170 MG/DL. CUSTOMER DELIVERED A BOLUS, AND WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732015 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR