BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6590878 · Received May 25, 2017

    Report

    Report Number
    3007981285-2017-15177
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 25, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HOME BUTTON ON THE TOUCHSCREEN WAS UNRESPONSIVE TO PRESSES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 161 - 157 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT THE TOUCHSCREEN WAS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373213 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR