BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR

    MDR report key: 3830802 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84916
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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

    IT WAS REPORTED THAT THE INSULIN IS LEAKING FROM RESERVOIR. THE BLOOD GLUCOSE READING WAS 115 MG/DL. CUSTOMER STATED IT WAS LEAKING PAST THE SECOND O-RING. CUSTOMER DOES NOT WANT TO GO THROUGH TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307887 RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG00W68

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR