BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 2874293 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-91386
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    October 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 ONE OPENED AND USED RESERVOIR. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER SPECIFICATIONS. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIR CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED PAST THE O-RINGS AND 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 H8095920

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR