BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% SURGISCREEN

    MDR report key: 1522402 · Received November 2, 2009

    Report

    Report Number
    2250051-2009-00306
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    September 27, 2009
    Report Date
    November 2, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED TESTING OF THE RETAINED PRODUCT TO ENSURE PRODUCT IS PERFORMING AS INTENDED. SATISFACTORY RESULTS WERE OBSERVED. REFER TO MEDWATCH # MFR 2250051-2009-00307 REGARDING A SECOND INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTING FALSE NEGATIVE REACTIONS IN AN ANTIBODY SCREEN USING VSS257. PT WAS LATER CONFIRMED TO HAVE AN ANTI-JKA. ANTIBODY SCREEN RESULTED IN A TRANSFUSION REACTION. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS EVENT AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS NA VSS257

    Patients

    Seq Age Sex Outcome Treatment
    1 Other