BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 2965239 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-91098
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 READING WAS 176MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67367 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR