BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 2230912 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82227
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED USED RESERVOIR AND PERFORMED MANUAL PRIME AND HIGH-PRESSURE TESTS. THE RESERVOIR PASSED THE TESTS AND NO LEAKS OR DEFECTS IN THE O-RINGS WERE OBSERVED DURING ANALYSIS. THE RESERVOIR WAS CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN WAS LEAKING FROM THE RESERVOIR. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7816077

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR