BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSERA ANTI-JKA

    MDR report key: 17547733 · Received August 15, 2023

    Report

    Report Number
    3011683976-2023-00010
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    September 21, 2022
    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 IS FIT FOR PURPOSE THEREFORE THIS COMPLAINT IS NOT UPHELD. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    END USER REPORTS FALSE NEGATIVE RESULT WITH ORTHOSERA ANTI-JKA (MTS) PRODUCT FD162M (6904548) LOT V224499 EXPIRY 05NOV22.TWO DONOR SAMPLES GENERATED NEGATIVE RESULTS WITH THE REAGENT ON ORTHO VISION WITH BUFFERED GEL CARD. ADDITIONAL TESTING WITH ANTI-JKA LOT V236730 GAVE EXPECTED POSITIVE REACTION, 2+ & 3+ RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197852 ORTHOSERA ANTI-JKA BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) FD162M V224499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown