BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2070385 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-81112
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH HIGH BLOOD GLUCOSE AND NOTICE THAT THE RESERVOIR HAD LEAKED PAST BOTH OF THE O-RINGS INTO RESERVOIR COMPARTMENT DURING NORMAL USE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7754500

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR