BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB BIOCLONE

    MDR report key: 4361527 · Received December 24, 2014

    Report

    Report Number
    2250051-2014-00127
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    December 5, 2014
    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 RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY 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

    CUSTOMER REPORTED ONE PATIENT ((B)(6) MALE WITH SICKLE CELL) WAS TESTED WITH ANTI-JKB LOT # JBB426A EXP 29JAN2015 AND THE RESULTS WERE LATER DETERMINED TO BE FALSE POSITIVE. CUSTOMER USED TWO MOLECULAR TESTS TO DETERMINE THE PATIENT IS ACTUALLY HOMOZYGOUS FOR THE JKA ANTIGEN AND NEGATIVE FOR THE JKB ANTIGEN. THE ISSUE WAS DISCOVERED ON (B)(6) 2014 WHEN MOLECULAR TESTING WAS PERFORMED AS A PREREQUISITE FOR DONOR MARROW TRANSPLANTATION OF THE SICKLE CELL PATIENT. THE FIRST MOLECULAR METHOD USED IMMUCOR HEA BEAD CHIP. THE DISCREPANCY BETWEEN SEROLOGIC AND MOLECULAR COULD NOT BE INVESTIGATED AT THAT TIME DUE TO LACK OF PATIENT SAMPLE. ON (B)(6) 2014, PATIENT RETURNED. SEROLOGIC TESTING WAS DONE AND THE RESULT WAS FALSE POSITIVE AS DESCRIBED ABOVE WITH JBB426A. DAT TESTING WAS DONE ON THE (B)(6) 2014 SAMPLE AND THE RESULT WAS NEGATIVE BY TUBE METHOD. ON (B)(6) 2014, A SECOND MOLECULAR METHOD WAS DONE USING BAGENE WITH KKD TYPE. RESULTS DEMONSTRATED THE PATIENT IS HOMOZYGOUS FOR JKA, NEGATIVE FOR THE JKB ANTIGEN. CUSTOMER ALSO TESTED TWO OTHER SOURCES OF ANTI-JKB FOR COMPARISON, EVEN THOUGH THEY WERE EXPIRED FOR INFORMATION ONLY (IMMUCOR ANTI-JKB AND ORGANON ANTI-JKB). TESTING WAS DONE BY TUBE METHOD AND THE REACTIONS WITH THE PATIENT'S (B)(6) 2014 SAMPLE GAVE JKB POSITIVE REACTIONS (REACTION GRADINGS NOT PROVIDED). CUSTOMER STATED ALL REAGENTS USED PASSED VISUAL INSPECTION AND QC TESTING. STORAGE AND HANDLING AS PER IFU. FOLLOW UP WITH CUSTOMER PROVIDED PREVIOUS MEDICAL HISTORY AND DEMONSTRATED THE FOLLOWING - INFREQUENT TRANSFUSIONS HAVE BEEN DONE SINCE THE PATIENT IS ON HYDROXUREA. DATES OF TRANSFUSIONS WERE: (B)(6) 2012 AND THEN ON (B)(6) 2014 (DONE AT OTHER HOSPITALS). CUSTOMER STATES THIS INFORMATION HAS RULED OUT THE POSSIBILITY OF THE TYPING DISCREPANCIES BEING DUE TO MIXED CELL POPULATION BETWEEN DONOR/RECIPIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850863 ANTI-JKB BIOCLONE ANTISERA KSZ ORTHO CLINICAL DIAGNOSTICS JBB426A

    Patients

    Seq Age Sex Outcome Treatment
    1