BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D BIOCLONE

    MDR report key: 4090330 · Received September 15, 2014

    Report

    Report Number
    2250051-2014-00096
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY PRODUCT AND LOT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER IS REPORTING DISCREPANT NEGATIVE D(RH1) ANTIGEN TYPING RESULTS FOR ONE PATIENTS¿ SAMPLE IN MANUAL TECHNIQUES. THE PATIENT WAS KNOWN BY THE LABORATORY TO BE D(RH1) ANTIGEN (B)(6). THE REPORTER SAID THAT, ON (B)(6) 2014 THE CUSTOMER HAD TESTED A PATIENTS¿ SAMPLE FOR D(RH1) ANTIGEN TYPING USING BIOCLONE ANTI-D LOT DB301A1, IN TUBE AND SLIDE METHODS AND THAT THEY HAD OBTAINED IN ALL TECHNIQUES, NEGATIVE RESULTS FOR D(RH1) ANTIGEN TYPING. THE REPORTER SAID THAT THE NEGATIVE REACTIONS WERE ALSO CHECKED WITH A MICROSCOPE. THE REPORTER SAID THAT THE SAME PATIENT'S SAMPLE WAS TESTED FOR D(RH1) ANTIGEN TYPING BY THE CUSTOMER USING A COMMERCIALLY AVAILABLE TECHNIQUE FROM TULIPS AND FOR WEAK D TESTING AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (NO FURTHER DETAIL WAS PROVIDED BY THE REPORTER). THE REPORTER SAID THAT THE SAME PATIENT SAMPLE WAS TESTED BY OTHER LABORATORIES AND WAS FOUND D(RH1) (B)(6) (NO FURTHER DETAIL WAS PROVIDED BY THE REPORTER). THE CUSTOMER SAID THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER SAID THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568921 ANTI-D BIOCLONE ANTISERA KSZ ORTHO CLINICAL DIAGNOSTICS DB301A1

    Patients

    Seq Age Sex Outcome Treatment
    1