BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3970007 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88373
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIGH BLOOD GLUCOSE READINGS AND A RESERVOIR LEAK. CUSTOMER STATED THAT THE INSULIN IS VISIBLE IN THE BATTERY AND RESERVOIR COMPARTMENT AS WELL AS UNDER THE SCREEN OF THE INSULIN PUMP. CUSTOMER ALSO STATED THAT THE LEAK IS PAST THE SECOND O-RING. CUSTOMER THEN MENTIONED A MOTOR ERROR. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 250 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446556 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG01294

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR