BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3CC

    MDR report key: 2020668 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-80555
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PLEASE SEE ALSO MFR REPORT NUMBERS 3004209178-2011-80554 AND 3004209178-2011-80556.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO DELIVERY ALARMS AND BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 646 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7738205

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization