BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-BIOCLONE

    MDR report key: 1413715 · Received July 2, 2009

    Report

    Report Number
    2250051-2009-00197
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    May 27, 2009
    Report Date
    July 2, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAINED TESTING OF THIS LOT OF PRODUCT. THE RETAINED VIALS OF BAA577A WERE TESTED WITH KNOWN ABO BLOOD GROUP DONORS. ALL RESULTS WERE AS EXPECTED. THE UNIT WAS RETURNED TO OCD FOR FURTHER INVESTIGATION. THE RETURNED UNIT FITS THE PATTERN OF A B(A) PHENOTYPE AS OUTLINED IN THE AABB TECHNICAL MANUAL AND THE LIMITATIONS OF PROCEDURE SECTION OF THE PRODUCT IFU. REFER TO MFR REPORT# 2250051-2009-00198 REGARDING TEST RESULTS WITH BAA578A.

    Description of Event or Problem · 1

    REFERENCE LAB REPORTED THAT A UNIT, WITH A BLOOD TYPE HISTORY OF B POS, IS REACTING 1+ WITH BAA577A AT A HOSPITAL SITE. THE UNIT HAS BEEN PREVIOUSLY TYPED WITH A COMPETITOR ANTI-A ANTISERUM AND HAS BEEN NEGATIVE. THE SAME UNIT IS REACTING 1+ WITH BAA578A. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-BIOCLONE ABO BLOOD GROUPING REAGENTS KSZ ORTHO-CLINICAL DIAGNOSTICS BAA577A

    Patients

    Seq Age Sex Outcome Treatment
    1