BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3854487 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85328
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING DIFFICULTY WITH THE RESERVOIR DURING THE MANUAL PRIME PROCESS. THE INSULIN CONTINUES TO COME OUT AFTER THE MOTOR HAS STOPPED. CUSTOMER HAS TRIED THIS PROCESS WITH OTHER INFUSION SETS AND HAS THE SAME PROBLEM. THE BLOOD GLUCOSE READING WAS 320 MG/DL. CUSTOMER WAS ADVISED TO REVERT TO A BACK UP PLAN UNTIL RECEIVING THE NEW RESERVOIR. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332619 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR