BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3013822 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-91984
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    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 PAST THE O-RINGS DURING THE NIGHT, AND SHE DID NOT NOTICED UNTIL SHE WOKE UP WITH HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 224MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115461 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR