BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3955336 · Received June 16, 2014

    Report

    Report Number
    3007981285-2014-01189
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING A CARTRIDGE ALARM 5 DURING THE LOAD PROCESS. WHEN THE CARTRIDGE WAS REMOVED, INSULIN WAS LEAKING FROM THE BOTTOM. THERE WAS NO IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352979 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR