BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN

    MDR report key: 1419156 · Received July 21, 2009

    Report

    Report Number
    2250051-2009-00225
    Event Type
    Malfunction
    Date Received
    July 21, 2009
    Date of Event
    June 22, 2009
    Report Date
    July 21, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CLINICAL DIAGNOSTICS (OCD) PERFORMED RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY WITH VS269 AND A PT WITH NO PREVIOUS TRANSFUSION HISTORY. IMMEDIATE SPIN CROSSMATCH IN TUBE WAS PERFORMED AND FOUR UNITS OF PACKED RED CELLS WERE TRANSFUSED. PT WAS LATER DETERMINED TO HAVE AN ANTI-E. OCD'S MEDICAL DIRECTOR HAS EVALUATED, THIS EVENT FOR SERIOUS INJURY. REVIEW OF THE CASE SHOWS THAT A WEAK ANTI-E WAS MISSED PRETRANSFUSION BY THE MANUAL GEL METHOD USING VS269. THIS EVENT HAS BEEN CLASSIFIED AS NOT A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS VS269

    Patients

    Seq Age Sex Outcome Treatment
    1