BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACLONE ANTI-C

    MDR report key: 17547731 · Received August 15, 2023

    Report

    Report Number
    3011683976-2023-00005
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    March 17, 2021
    Report Date
    August 10, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHR
    PMA / PMN Number
    125599
    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. THE INTERNAL INVESTIGATION HAS CONSISTED OF BOTH BATCH MANUFACTURING RECORD (BMR) REVIEW AND INVESTIGATIVE TESTING. ALBACLONE® ANTI-C PRODUCT Z064U LOT V223588 IS FIT FOR PURPOSE THEREFORE THIS COMPLAINT IS DEEMED UNCONFIRMED. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    END USER REPORTS THAT A SAMPLE FROM A PATIENT DIAGNOSED WITH MULTIPLE MYELOMA REACTED VARIABLY WITH ANTI-C REAGENTS. ALBACLONE®ANTI-C, PRODUCT Z064U, LOT V223588, EXP29JUN22 REACTED 1-2+ WITH THE RETICULOCYTE ENRICHED SAMPLE WHEREAS BIO-RAD ANTI-C WAS NONREACTIVE. INITIAL MOLECULAR TESTING PREDICTED THE PHENOTYPE TO BE C NEGATIVE. UPON REVIEW OF THE REPORT SUBMITTED BY ARC BIOMEDICAL HEADQUARTERS QUALITY, IT WAS NOTED THAT THE REACTIVITY WITH Z064U WAS REPORTED AS MIXED FIELD. US TECHNICAL FOLLOWED UP WITH THE END USER TO ASK IF IT WAS POSSIBLE THAT THE RETICULOCYTE HARVEST CONTAINED A SMALL POPULATION OF DONOR RED CELLS. BOTH ALBACLONE®ANTI-C, PRODUCT Z064U, AND THE BIORAD REAGENT CONTAIN THE MS24 CLONE AND WOULD BE EXPECTED TO REACT SIMILARLY WITH VARIANT PHENOTYPES. HOWEVER, ALBACLONE®ANTI-C, PRODUCT Z064U CONTAINS POTENTIATORS WHILE THE BIO-RAD REAGENT DOES NOT (PER THE IFU). THIS MIGHT ALLOW IT TO DETECT A MINOR CELL POPULATION PRESENT IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197850 ALBACLONE ANTI-C BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) Z064U V223588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown