BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACLONE® ANTI-D BLEND

    MDR report key: 17547736 · Received August 15, 2023

    Report

    Report Number
    3011683976-2023-00011
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    September 27, 2022
    Report Date
    August 10, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHR
    PMA / PMN Number
    125314
    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 CONCLUDED ALBACLONE® ANTI-D BLEND PRODUCT Z041U LOTS V229305 TO BE SATISFACTORY IN LINE WITH OUR PRODUCT IFU, PROCEDURES AND SPECIFICATIONS THEREFORE THIS COMPLAINT IS DEEMED NOT UPHELD. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO RELEVANT TESTS/LABORATORY DATA RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197855 ALBACLONE® ANTI-D BLEND BLOOD GROUPING REAGENT QHR ALBA BIOSCIENCE LIMITED (LTD.) Z041U V229305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown