BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4791023 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-59067
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER STATED THAT THE RESERVOIR WAS LEAKING WHEN BEING REMOVED. THE CUSTOMER EXPLAINED THAT INSULIN WAS DRIPPING OUT OF THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 121 MG/DL. THE CUSTOMER CONFIRMED THE LEAK WAS AT THE BACK OF THE RESERVOIR AND THAT THERE WAS LIQUID IN THE RESERVOIR COMPARTMENT. THE CUSTOMER STATED THAT THE LEAK WAS PAST THE 2ND O-RING. IN REGARDS TO THE INSULIN PUMP, THE CUSTOMER COULD HEAR THE MOTOR TURNING, BUT THE PISTON WAS NOT MOVING. THE CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335706 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H7916246

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR