BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3896925 · Received May 22, 2014

    Report

    Report Number
    3007981285-2014-00760
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A F/U MDR WILL BE FILED.

    Description of Event or Problem · 1

    REC'D INFO REGARDING A CARTRIDGE ALARM 25 AND MULTIPLE CARTRIDGE ALARM 19 DURING BASAL DELIVER. THERE IS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307026 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002947

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR