BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSERA ANTI-JKA

    MDR report key: 17547730 · Received August 15, 2023

    Report

    Report Number
    3011683976-2023-00006
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 20, 2021
    Report Date
    August 10, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHR
    PMA / PMN Number
    125568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - OTHER - INVESTIGATION PERFORMED ON RETAINED SAMPLE FORON THE SAME BATCH. INTERNAL INVESTIGATION CONSISTED OF BOTH BATCH MANUFACTURING RECORD (BMR) REVIEWS AND INVESTIGATIVE TESTING. OUR INVESTIGATION HAS CONFIRMED THAT ORTHOTM SERA ANTI-JKA PRODUCT FD162M LOT V224499 TO BE FIT FOR PURPOSE THEREFORE THIS COMPLAINT IS NOT UPHELD. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS CNC-2207.

    Description of Event or Problem · 0

    END USER REPORTS THAT WHEN TESTING A DONOR SAMPLE WITH ORTHOSERA ANTI-JKA, PRODUCT FD162M, LOT V224499, EXP 05NOV22 ON THE ORTHO VISION SYSTEM THEY RETURNED A FALSE NEGATIVE RESULT. THE DONOR PRODUCED A NEGATIVE RESULT FOR BOTH ANTI-JKA & ANTI-JKB; AND BASED ON THE RARITY OF THIS PHENOTYPE, THE END USER REPEATED THE TESTING MANUALLY WITH ORTHO ANTISERA AND WERE ABLE TO DUPLICATE THE NEGATIVE RESULT FOR THE JKB ANTIGEN TESTING, HOWEVER THEY OBSERVED A 2+ REACTION AT IMMEDIATE SPIN WITH ORTHO ANTI-JKA LOT JAB444A. NO REPEAT TESTING ON THE VISION OR MANUAL GEL METHOD WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963469 ORTHOSERA ANTI-JKA BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) FD162M V224499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown