BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2232656 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-82662
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 FROM BACK OF THE RESERVOIR BARREL WAS LEAKING INTO THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7762363

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR