BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSERA ANTI-JKA

    MDR report key: 17547735 · Received August 15, 2023

    Report

    Report Number
    3011683976-2023-00013
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    March 28, 2023
    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 DETERMINED ORTHOTMSERA ANTI-JKA PRODUCT FD162M LOT V236730 TO BE FIT FOR PURPOSE THEREFORE THIS COMPLAINT IS NOT UPHELD ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS CNC-2730, CNC-2731 AND CNC-2732.

    Description of Event or Problem · 0

    END USER REPORTS A FALSE NEGATIVE RESULT WITH ORTHOSERA ANTI-JKA PRODUCT FD162M (6904548) LOT V236730 EXPIRY 04AUG23. THE END USER REPORTS FIVE DONOR SAM.LES GENERATED NEGATIVE RESULTS WITH THE REAGENT ON ORTHO VISION WITH MTS BUFFERED GEL CARD. ADDITIONAL TESTING WITH ANTI-JKA LOT V239155 EXPIRY 30SEP23 GAVE THE EXPECTED POSITIVE REACTION, 2+ & 3+ RECORDED, RESULTING IN 3 COMPLAINTS FOR LOT V236730 FROM 19AUG22 TO 16MAR23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197854 ORTHOSERA ANTI-JKA BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) FD162M V236730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown