BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 2909920 · Received January 11, 2013

    Report

    Report Number
    1034569-2013-00009
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 10, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE FILES FOR INITIAL TESTING ON THE ECHO SHOWED THAT A NEGATIVE REACTION WAS OBTAINED IN THE ANTI-A TEST WELL. THE IMMUCOR PRODUCT INVESTIGATION LAB CONFIRMED THE REACTIVITY OF ANTI-A BY TESTING RETENTION ANTISERA, ANTI-A (LOT 101881), BY TUBE METHOD WITH KNOWN REFERENCELLS A1 (LOT 118898), B (LOT 113898), A2 (LOT 112689), AND O (LOT 114188) ALONG WITH KNOWN GROUP TYPING OF IN-HOUSE DONORS. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED CELLS AND ALL IN-HOUSE DONORS EXHIBITED THE EXPECTED REACTIVITY. HEMAGGLUTINATION TESTING WAS PERFORMED ON THE CUSTOMERS SUBMITTED SAMPLE WITH RETENTION ANTI-A, LOT 101881. CONTROLS PERFORMED AS EXPECTED AND THE CUSTOMERS SAMPLE EXHIBITED NEGATIVE REACTIVITY. THE GROUP ASSAY WAS PERFORMED ON THE ECHO. QC PERFORMED AS EXPECTED AND THE CUSTOMERS SAMPLE RESULTED AS NEGATIVE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE REACTIVITY OBSERVED APPEARS TO BE UNIQUE TO THE NATURE OF THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ABO MISTYPE OCCURRED DURING VALIDATION ON THE ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17223 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 101881

    Patients

    Seq Age Sex Outcome Treatment
    1