BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 2842280 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-90871
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INSPECTED TWO OPENED AND USED RESERVOIRS AND PERFORMED MANUAL PRIME AND HIGH-PRESSURE TESTS PER SPECIFICATION, ALL RESERVOIRS PASSED. NO LEAKAGE OR OCCLUDED ANOMALIES WERE OBSERVED DURING TESTING. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIRS WERE CONNECTED AND LOCKED PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN FROM THE RESERVOIR WAS LEAKING PAST THE O-RINGS INTO THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3ML FRN FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8258414

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR