BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3013869 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-91999
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 SPECIFICATION. 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

    IT WAS REPORTED THAT INSULIN FROM THE RESERVOIRS LEAKED PAST THE O-RINGS AND INTO THE RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 422MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115676 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8489386

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR