BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB BIOCLONE ANTISERA

    MDR report key: 3457945 · Received November 8, 2013

    Report

    Report Number
    2250051-2013-00390
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    September 18, 2013
    Report Date
    November 8, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. TESTING OF RETURNED VIALS OF ANTISERA LOT #JBB423A WAS ALSO PERFORMED. SATISFACTORY RESULTS WERE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH DONOR # (B)(4) AND JKB ANTIGEN TYPING PERFORMED WITH THE ORTHO ANTI-JKB LOT# JBB423A. CUSTOMER REPORTS THE INITIAL TESTING WAS PERFORMED ON (B)(6) 2013 WHERE DONOR # (B)(6) WAS TESTED AGAINST THE ORTHO ANTI-JKB LOT# JBB423A AND WAS REPORTED TO BE JKB NEGATIVE. QUALITY CONTROLS WERE CONFIRMED TO BE ACCEPTABLE WITH IMMUCOR HETEROZYGOUS DONORS ON THE DAY OF USE. CUSTOMER STATED THAT THE DONOR WAS SELECTED TO BE FROZEN BASED ON ADDITIONAL ANTIGEN TYPING. CUSTOMER'S SOP CALLS FOR ALL ANTIGEN TYPING TO BE REPEATED BEFORE THE UNITS WILL BE FROZEN. CUSTOMER REPORTED THIS REPEAT JKB TYPING WAS PERFORMED ON (B)(6) 2013 AND WAS INCONSISTENT WITH THE ORIGINAL RESULTS. DONOR # (B)(6) WAS NOW YIELDING A 2-3+ REACTION AGAINST THE SAME LOT OF ANTI-JKB. CUSTOMER REPORTED MAKING MULTIPLE ATTEMPTS TESTING THE DONOR AND RESULTS WOULD BE INCONSISTENTLY POSITIVE AND NEGATIVE. QUALITY CONTROL WAS CONFIRMED TO BE ACCEPTABLE FOR THE DAY OF USE. ALL REAGENTS HAD BEEN STORED ACCORDING TO THEIR IFU AND HAD NORMAL APPEARANCE. CUSTOMER CONFIRMED THAT THE CORRECT PROCEDURE FOR TRADITIONAL TUBE METHOD WAS BEING FOLLOWED WITH A 30MIN ROOM TEMP INCUBATION. CUSTOMER INDICATED THAT THE UNIT WOULD NOT BE USED FOR ANY PATIENT KNOW TO HAVE AN ANTI-JKB. CUSTOMER REQUESTED THE REPLACEMENT OF BOTH VIALS OF THE JKB ANTISERA FOR AN ALTERNATIVE LOT. REPLACEMENT ANTI-JKB LOT # JBB424A WAS SUPPLIED TO THE CUSTOMER. CUSTOMER REPORTED FURTHER TESTING THE LISTED DONOR (B)(6) AND RESULTS WERE NOW CONSISTENTLY POSITIVE WITH BOTH LOT# JBB423A (2+ REACTION) AND JBB424A (2+ REACTION). THE TESTING WAS PERFORMED IN PARALLEL ON (B)(6) 2013. CUSTOMER INDICATED THEIR CONFIDENCE THAT THE LISTED DONOR IS A JKB VARIANT AND THIS IS THE CAUSE OF THE INCONSTANCIES. CUSTOMER REPORTED SENDING THE DONOR SEGMENT OUT FOR MOLECULAR JKB STUDIES. NO ADDITIONAL TESTING OF THE DONOR BY OCD WAS REQUIRED. CUSTOMER AGREED TO RETURN VIALS OF ANTI-JKB ANTISERA LOT# JBB423A FOR TESTING BY OCD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579970 ANTI-JKB BIOCLONE ANTISERA RED BLOOD CELL REAGENT KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1