BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-CLONE ANTI-C (MONOCLONAL) SERIES 2

    MDR report key: 11639337 · Received April 8, 2021

    Report

    Report Number
    1034569-2021-00009
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHR
    UDI-DI
    10888234001355
    PMA / PMN Number
    103498/5033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 9, 2021 IMMUCOR CONFIRMED REACTIVITY OF RETENTION ANTI-C MONOCLONAL LOT 936210A WITH FOUR HETEROZYGOUS C ANTIGEN POSITIVE CELLS AND FOUR C ANTIGEN NEGATIVE CELLS USING RETENTION PANOCELL-20 LOT 50556 AND PANOCELL-16 LOT 02592. CONTROLS PERFORMED AS EXPECTED AND ALL THE C POSITIVE CELLS RESULTED AS EXPECTED. TESTING PERFORMED PER PACKAGE INSERT INSTRUCTIONS. RETENTION PRODUCT PERFORMED AS EXPECTED. ON FEBRUARY 11, 2021 IMMUCOR CONFIRMED REACTIVITY OF RETURN ANTI-C MONOCLONAL LOT 936210A WITH FOUR HETEROZYGOUS C ANTIGEN POSITIVE CELLS AND FOUR C ANTIGEN NEGATIVE CELLS USING RETENTION PANOCELL-20 LOT 50556 AND PANOCELL-16 LOT 02592. CONTROLS PERFORMED AS EXPECTED AND ALL THE C POSITIVE CELLS RESULTED AS EXPECTED. TESTING PERFORMED PER PACKAGE INSERT INSTRUCTIONS. RETURN PRODUCT PERFORMED AS EXPECTED. ON FEBRUARY 11, 2021 IMMUCOR TESTED RETURN SEGMENTS FROM UNIT W0352 21 11693600W WITH RETENTION AND RETURN ANTI-C (MONOCLONAL) GAMMA-CLONE LOT 936210A. CONTROLS PERFORMED AS EXPECTED. THE SEGMENT FROM UNIT W0352 21 11693600W TESTED NEGATIVE WITH BOTH RETENTION AND RETURN ANTI-C (MONOCLONAL) GAMMA-CLONE LOT 936210A. THE IMMUCOR INTERNAL RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON MARCH 10, 2021 IMMUCOR BECAME AWARE OF AN EVENT INVOLVING AN UNEXPECTED POSITIVE REACTION FOR A UNIT FROM A DONOR WHO WAS HISTORICALLY NEGATIVE FOR C ANTIGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530005 GAMMA-CLONE ANTI-C (MONOCLONAL) SERIES 2 ANTI-C (MONOCLONAL) BLOOD GROUPING REAGENT QHR IMMUCOR, INC. 936210-A 10888234001355

    Patients

    Seq Age Sex Outcome Treatment
    1