BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL I11

    MDR report key: 2500827 · Received March 23, 2012

    Report

    Report Number
    9610824-2012-00032
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 23, 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 YIELDED A (B)(6) WITH THE ANTI-LE(B) REAGENT FROM ORTHO ALTHOUGH THE ANTIGEN PROFILE SHEET LISTS IT AS LE(A-B+). WE RECEIVED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE ANTI-LE(B) REAGENT OF ORTHO. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF BIOTESTCELL-I11 AND THIS TESTING CONFIRMED THE CUSTOMER´S RESULTS. FURTHER TESTINGS HAD CONFIRMED THAT THE AFFECTED CELL #10 IS LE(A-B-). BECAUSE OF THE MISTYPING OF CELL#10 A RISK ANALYSIS WAS PERFORMED. THE RESULT OF THIS RISK ANALYSIS WAS THAT THERE IS NO RISK FOR USERS OF BIOTESTCELL-I11: BIOTESTCELL-I11 IS USED FOR THE IDENTIFICATION OF UNEXPECTED ANTIBODIES. THE 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. 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 8205011

    Patients

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