BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3211942 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95442
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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 THREE RANDOMLY SEALED RESERVOIRS. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIRS PASSED PER INSPECTION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WERE FOUND. RESERVOIRS CONNECTED AND LOCKED IN PLACE PROPERLY. INSPECTED THREE OPENED AN USED RESERVOIRS. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIRS PASSED PER INSPECTION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WERE FOUND. RESERVOIRS CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    IT WAS 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
    311210 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8491921

    Patients

    Seq Age Sex Outcome Treatment
    1