BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOTM SERA ANTI-FYB

    MDR report key: 17547727 · Received August 15, 2023

    Report

    Report Number
    3011683-2023-00008
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    June 9, 2022
    Report Date
    August 10, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHR
    PMA / PMN Number
    125342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 : 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 ORTHO¿ SERA ANTI-FYB PRODUCT FD153M LOT V231170 TO BE 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 A FALSE NEGATIVE RESULT WHEN ANTIGEN TYPING A DONOR WITH ORTHOTM SERA ANTI-FYB, PRODUCT FD153M, LOT V231170, EXP30JAN23 USING MANUAL METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963466 ORTHOTM SERA ANTI-FYB BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) FD153M V231170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown