BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR

    MDR report key: 2944797 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-90824
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 THAT INSULIN FROM THE RESERVOIR LEAKED INTO THE RESERVOIR COMPARTMENT. THE BLOOD GLUCOSE WAS 436MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48536 RESERVOIR RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR