BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 2PK 3ML

    MDR report key: 3180916 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94902
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 INSPECTION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE 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 INTO THE RESERVOIR COMPARTMENT. THE BLOOD GLUCOSE READING WAS 441MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279708 RESERVOIR 2PK 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332AT

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR