BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE® REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION

    MDR report key: 17547728 · Received August 15, 2023

    Report

    Report Number
    3011683976-2023-00009
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    September 16, 2022
    Report Date
    August 10, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHT
    PMA / PMN Number
    125337
    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 REPLICATED THE FINDINGS OF THE END USER HOWEVER THE COMPLAINT IS NOT UPHELD AS THE DONOR IS M NEGATIVE; THE REACTIVITY OBSERVED IS DUE REACTIVITY OF HENSCHAW ANTIGEN REACTING WITH THE ANTI-M CELL LINE 2514E6 AS DETAILED IN THE REAGENT IFU. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    END USER REPORTS THAT WHEN TESTING WITH CELL 16 (M- N+) OF ALBACYTE® REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL) PRODUCT Z473U LOT V251770 EXPIRY 10OCT22, TWO POSITIVE REACTION WAS OBSERVED WITH GRIFOLS ANTI-M (REACTION GRADE 4+).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963467 ALBACYTE® REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION REAGENT RED BLOOD CELLS QHT ALBA BIOSCIENCE LIMITED (LTD.) Z473U V251770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown