BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE® RHD NEGATIVE SCREENING PANEL

    MDR report key: 17547732 · Received August 15, 2023

    Report

    Report Number
    3011683-2023-00003
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    March 1, 2021
    Report Date
    August 10, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHR
    UDI-DI
    05060242470776
    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. PRODUCT Z466 IS NOT APPROVED IN US; BUT A SIMILAR PRODUCT, Z464U ALBACYTE® EXPANDED RH NEGATIVE ANTIBODY SCREEN IS APPROVED IN US. OUR INVESTIGATION HAS CONFIRMED ALBACYTE® RHD NEGATIVE CAT REAGENT RED CELLS FOR ANTIBODY SCREENING PRODUCT Z466 LOT V230970 TO BE FIT FOR PURPOSE THEREFORE THIS COMPLAINT IS DEEMED UNCONFIRMED. QUOTIENT REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    END USER HAS OBSERVED THAT WHEN TESTING PATIENTS WHO HAVE HAD RECENT ANTI-D PROPHYLAXIS, WITH ALBACYTE® RHD NEGATIVE SCREENING PANEL, PRODUCT Z466, LOT V230970, EXP 29MAR21 THEY APPEAR TO BE FREQUENTLY PICKING UP ANTI-C AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197851 ALBACYTE® RHD NEGATIVE SCREENING PANEL BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) Z466 V230970 05060242470776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown