BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-E (MONOCLONAL) SERIES 1

    MDR report key: 841706 · Received April 26, 2007

    Report

    Report Number
    1034569-2007-00087
    Event Type
    Malfunction
    Date Received
    April 26, 2007
    Date of Event
    April 2, 2007
    Report Date
    April 26, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLAINED TO THE CUSTOMER THAT THE REAGENTS ARE MANUFACTURED WITH DIFFERENT CLONES OF CELLS. THE PACKAGE INSERT LIMITATION FOR IMMUCOR ANTI-E STATES "THE E ANTIGEN MAY BE ONLY WEAKLY EXPRESSED ON THE RED BLOOD CELLS OF SOME BLACKS AND SUCH RED BLOOD CELLS MAY REACT WEAKLY WITH ANTI-E. SOME HRS- OR HRB- RED BLOOD CELLS MAY FAIL TO REACT WITH ANTI-E. ANTI-E MAY GIVE SLIGHTLY WEAKER REACTIONS IN THE ABSENCE OF THE C ANTIGEN." THE SEROLOGICAL REACTIVITY REPORTED BY THE CUSTOMER FOR THE PT SAMPLE SUGGEST THE PT IS HRB-.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE GETTING UNEXPECTED NEGATIVE REACTIONS WITH ANTI-E (MONOCLONAL) SERIES 1 WITH A PATIENT SAMPLE KNOWN TO CONTAIN ANTI-E. THE SAME PT, WHEN TESTED WITH GAMMACLONE ANTI-E (MONOCLONAL BLEND), RESULTED IN POSITIVE REACTIONS 2+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-E (MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR 5P7614L

    Patients

    Seq Age Sex Outcome Treatment
    1 YR GAMMACLONE ANTI-E