BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVOY 500 SERUM CONTROL 1 & 2

    MDR report key: 1477425 · Received September 15, 2009

    Report

    Report Number
    MW5012763
    Event Type
    Injury
    Date Received
    September 15, 2009
    Date of Event
    July 1, 2009
    Manufacturer
    VITAL DIAGNOSTICS INC.
    Product Code
    JJY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 08/07/2009, CONTACTED VITAL DIAGNOSTICS CONCERNING REAGENTS. AT THAT TIME WE WERE NOTIFIED OF CHANGE IN CONTROL/CALIBRATION RANGE/SET POINTS. BOXES OF THE CONTROL/CALIBRATION WERE NOT MARKED CHANGE, NOR DID WE RECEIVE AN E-MAIL, FAX OR MAIL NOTIFICATION OF CHANGE. MFR CHANGED CAL/RANGE/SET POINT WITH NO "NOTICE" WITHIN SAME LOT NUMBER. DOSE OR AMOUNT: NA. DATES OF USE: 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVOY 500 SERUM CONTROL 1 & 2 NONE JJY VITAL DIAGNOSTICS INC. 9141010
    2 ENVOY 500 SERUM CALIBRATOR NONE JIX VITAL DIAGNOSTICS INC. 8345010B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other