BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB BIOCLONE

    MDR report key: 4361572 · Received December 24, 2014

    Report

    Report Number
    2250051-2014-00128
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    March 21, 2013
    Report Date
    December 24, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED BATCH REVIEW AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. LOT EXPIRED ON 20NOV2013 SO NO RETAIN TESTING WAS POSSIBLE. SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4). LOT EXPIRED ON 20NOV2013 SO NO RETAIN TESTING IS POSSIBLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ONE PATIENT WAS TESTED ON (B)(6) 2013 WITH ANTI-JKB LOT# JBB420A EXP 20NOV2013 AND THE RESULTS WERE LATER DETERMINED TO BE FALSE POSITIVE. IN 2014, CUSTOMER USED TWO MOLECULAR TESTS TO DETERMINE THAT THE PATIENT IS ACTUALLY HOMOZYGOUS FOR THE JKA ANTIGEN AND NEGATIVE FOR THE JKB ANTIGEN. CUSTOMER IS REPORTING RESULTS AFTER INVESTIGATION WAS PERFORMED AS A RESULT OF MOLECULAR TESTING. CUSTOMER BELIEVES THIS ISSUE TO BE RELATED TO THE PATIENT'S UNIQUE ANTIGEN EXPRESSION, NOT DUE TO A PRODUCT ISSUE. ALL QC TESTING DONE WITH ANTI-JKB HAD PASSED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850731 ANTI-JKB BIOCLONE ANTISERA FOR ANTIGEN TYPING KSZ ORTHO CLINICAL DIAGNOSTICS JBB420A

    Patients

    Seq Age Sex Outcome Treatment
    1