BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-N (MURINE MONOCLONAL) GAMMA-CLONE

    MDR report key: 23551512 · Received November 14, 2025

    Report

    Report Number
    1034569-2025-00029
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 14, 2025
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHR
    UDI-DI
    10888234001904
    PMA / PMN Number
    102134/5063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DONOR SAMPLES OR REAGENT WERE RETURNED TO IMMUCOR, SO NO FURTHER INVESTIGATION WAS POSSIBLE. ON (B)(6) 2025 IMMUCOR CONFIRMED REACTIVITY OF RETENTION ANTI-N (MURINE MONOCLONAL) GAMMA-CLONE LOT NUMBER 994035 USING 4 N POSITIVE AND 4 N NEGATIVE CELLS. CONTROLS PERFORMED AS EXPECTED. ALL POSITIVE CELLS RESULTED 3+ POSITIVE AND ALL NEGATIVE CELLS RESULTED NEGATIVE. RETENTION PRODUCT PERFORMED AS EXPECTED. NO DONOR SAMPLES OR REAGENT WERE RETURNED TO IMMUCOR, SO NO FURTHER INVESTIGATION WAS POSSIBLE. NO PATIENT INJURY OR HARM WAS REPORTED. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULTS FOR TWO DONOR SAMPLES WITH ANTI-N (MURINE MONOCLONAL) GAMMA-CLONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165121 ANTI-N (MURINE MONOCLONAL) GAMMA-CLONE ANTI-N BLOOD GROUPING REAGENT QHR IMMUCOR, INC. 994035 10888234001904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown