BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 5611131 · Received April 27, 2016

    Report

    Report Number
    1034569-2016-00087
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    March 21, 2016
    Report Date
    April 27, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN BL102691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR'S PRODUCT INVESTIGATIONS LAB CONFIRMED THE REACTIVITY OF ANTI-A, LOT 101755, IN TUBE, USING RETENTION REFERENCELLS A1, LOT 111070, A2 LOT 112070, B LOT 113070, O 114070, AND VARIOUS KNOWN ABO TYPE IN-HOUSE DONOR SAMPLES. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS EXHIBITED THE EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED POSITIVE ABO TYPING RESULTS WITH ANTI-A (MURNIE MONOCLONAL) SERIES 1, LOT 101755.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267744 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 101755

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO