BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL)

    MDR report key: 19825923 · Received July 25, 2024

    Report

    Report Number
    3011683976-2024-00011
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    QHT
    PMA / PMN Number
    125337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION CONSISTED OF REVIEW OF THE IFU AND INFORMATION PROVIDED BY THE END USER. OUR INVESTIGATION HAS CONFIRMED THAT ALBACYTE® REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL) PRODUCT Z473U, LOT V274561, EXPIRY: 12-AUG-24 TO BE FIT FOR PURPOSE AND CONFIRMED THE OFF LABEL USE OF THE PRODUCT BY THE END USER. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    END USER REPORTS WEAKER THAN EXPECTED REACTIVITY WITH ALBACYTE® REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL) PRODUCT Z473U, LOT V274561, EXPIRY: 12-AUG-24 WHEN COMPARED TO ORTHO RED CELL PRODUCTS, TESTING ON MTS GEL. PRODUCT IS SUPPLIED AS 3% RED CELLS FOR CONVENTIONAL TUBE METHOD ONLY, HOWEVER, THE END USER CONVERTS THE PRODUCTS TO 0.8% FOR OFF-LABEL TESTING ON GEL CARD METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409051 ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL) REAGENT RED BLOOD CELLS QHT ALBA BIOSCIENCE LIMITED (LTD.) Z473U V274561

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention