BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3951902 · Received July 7, 2014

    Report

    Report Number
    3007981285-2014-01985
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED, THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE DEVICE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFO CUSTOMER PUMP HAS STOPPED WORKING. CUSTOMER STATES THAT HE RECEIVED A LOW POWER ALARM AT 40% AND PLUGGED THE PUMP INTO A POWER SOURCE, PUMP RESET SHORTLY AFTER. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS SLIGHTLY ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394935 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other