BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3920293 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86613
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 STATED THAT THE INSULIN PUMP WAS DAMAGED AND SOME BROWN STUFF GOT INTO IT. THE PREVIOUS INSULIN PUMP HAS BEEN REPLACED. THE BLOOD GLUCOSE READING IS 186 MG/DL. CUSTOMER REPORTED LEAKING RESERVOIRS. CUSTOMER DECLINED TO TROUBLESHOOT THE LEAKING RESERVOIRS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397060 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR