BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 2771128 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-89857
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    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 ANOMALIES WERE OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIR CONNECTED AND LOCKED IN PLACE PROPERLY.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNEXPLAINED HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER STATED THAT INSULIN FROM THE RESERVOIR WAS LEAKING PAST THE O-RINGS. 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 H8241432

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR