BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-C (MONOCLONAL)

    MDR report key: 2514140 · Received April 3, 2012

    Report

    Report Number
    1034569-2012-00063
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 30, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 103498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. SAMPLE -(B)(6) RESULTED AS C NEGATIVE BY THE ECHO INSTRUMENT (WELL VISUALLY APPEARED POSITIVE WITH VERY WEAK AGGLUTINATION). THE CUSTOMER STATED THIS SAMPLE WAS IDENTIFIED AS BEING C POSITIVE BY THE ARC AND IS POSITIVE (3+) IN TUBE AND POSITIVE (4+) WHEN TESTED ON THE ECHO AT THEIR OTHER FACILITY. THE SAMPLE WAS REPEATED WITH A NEW LOT OF ANTI-C (LOT# 936061). POSITIVE (1+) REACTIONS WERE OBTAINED. RESULTS VISUALLY APPEARED TO BE LOOSELY SWIRLED AGGLUTINATION. CUSTOMER WAS ADVISED TO PERFORM A FULL RH PHENOTYPE ON THE SAMPLE AND TO ALSO RETEST FOR THE C ANTIGEN IN TUBE ALONGSIDE A KNOWN C ANTIGEN NEGATIVE CONTROL TO STANDARDIZE THE SHAKING OF TUBES. SAMPLE-(B)(6), LITTLE C WAS 3+, BIG E WAS 3+ AND LITTLE E WAS 2+. TUBE TESTING FOR BIG C WAS ALSO POSITIVE. CUSTOMER WAS ASKED TO REPEAT TESTING ON THE ECHO. POSITIVE (3+) RESULTS FOR THE C ANTIGEN WERE OBTAINED. CUSTOMER WAS MADE AWARE THAT HETEROZYGOUS SAMPLES WILL HAVE WEAKER REACTIVITY. IN-HOUSE TESTING WAS PERFORMED ON RETENTION PRODUCTS. THE AG_C RH2 ASSAY WAS PERFORMED ON TWO C POSITIVE ANTIGEN IN-HOUSE DONORS USING RETENTION CMT PLATES, LOT NU514 AND ANTI-C, LOT 936060 ON THE ECHO. CONTROLS PERFORMED AS EXPECTED AND IN-HOUSE DONORS RESULTED C+ AS EXPECTED. PERFORMED HEMAGGLUTINATION TUBE TESTING ON TWO C POSITIVE ANTIGEN IN-HOUSE DONORS USING RETENTION ANTI-C, LOT 936060. CONTROLS PERFORMED AS EXPECTED AND IN-HOUSE DONORS EXHIBITED 2+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. ALL ECHO CUSTOMERS WERE NOTIFIED THAT NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON THE ECHO ARE TO BE VISUALLY INSPECTED PRIOR TO RELEASE OF RESULTS. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN TECHNICAL COMMUNICATION (B)(4) ON NOVEMBER 25, 2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIONS WERE OBTAINED WHILE PERFORMING C ANTIGEN TESTING ON THE ECHO INSTRUMENT USING BLOOD GROUPING REAGENT ANTI-C (MONOCLONAL) GAMMA-CLONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-C (MONOCLONAL) BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 936060

    Patients

    Seq Age Sex Outcome Treatment
    1