BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1057086 · Received May 28, 2008

    Report

    Report Number
    2250051-2008-00282
    Event Type
    Injury
    Date Received
    May 28, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED PT WAS BLEEDING PROFUSELY, WITH NO SUSPECTED TRANSFUSION REACTION REPORTED. RETROSPECTIVE TESTING PERFORMED BY CUSTOMER USING VSS165 AND SAMPLE DRAWN WAS NEGATIVE. THE SAME SAMPLE TESTED AGAINST VSS169 PRODUCED A 1+ REACTION. ORTHO CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAIN TESTING OF VSS165 AND CONFIRM THE REACTIVITY OF THE E ANTIGEN. RESULTS WERE SATISFACTORY. THE POTENTIAL MALFUNCTION OF THE DEVICE WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1