BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL I11

    MDR report key: 2463896 · Received February 22, 2012

    Report

    Report Number
    9610824-2012-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CELL #10 OF BIOTESTCELL-I11 SHOWED A NEGATIVE REACTION WITH THE ANTI-LE(B) REAGENT FROM ORTHO ALTHOUGH THE ANTIGEN PROFILE SHEET LISTS IT AS LE(A-B+). WE RECEIVED THE SUPPOSEDLY DEFECTIVE PRODUCT AND THE ANTI-LE(B) REAGENT OF ORTHO. OUR QUALITY CONTROL LABORATORY RETESTED THE SUPPOSEDLY DEFECTIVE PRODUCT AND COULD CONFIRM THE CUSTOMER´S RESULT. FURTHER TESTINGS CONFIRMED THAT THE AFFECTED CELL #10 IS LE(A-B-).THE SAME DAY WE RECEIVED THE COMPLAINT THE ALLEGEDLY DEFECTIVE LOT EXPIRED, BUT DUE TO THE CONFIRMED COMPLAINT A RISK ANALYSIS WAS PERFORMED. THE RESULT OF THIS RISK ANALYSIS WAS THAT THERE IS NO RISK FOR USERS OF BIOTESTCELL-I11: BIOTESTCELL-I11'S INTENDED USE IS THE IDENTIFICATION OF UNEXPECTED ANTIBODIES. ANTIBODY LE(B) HAS NO CLINICAL SIGNIFICANCE. ANTI-LE(B) DOES NOT CAUSE A TRANSFUSION REACTION. IN ADDITION TO THE AFFECTED CELL #10 THERE ARE MORE LE(B) POSITIVE CELLS DOCUMENTED IN THE ANTIGEN PROFILE SHEET OF BIOTESTCELL-I11. THEREFORE THE IDENTIFICATION OF AN ANTI-LE(B) IS POSSIBLE DESPITE THE FAILURE IN THE ANTIGEN PROFILE SHEET. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT, BUT DUE TO THE CONFIRMED COMPLAINT FURTHER ACTIONS WERE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL I11 BIOTESTCELL I-11 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8149011

    Patients

    Seq Age Sex Outcome Treatment
    1 ORTHO ANTI-LEB, LOT LBB240A