BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL- I11

    MDR report key: 2341591 · Received November 18, 2011

    Report

    Report Number
    9610824-2011-00166
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 24, 2011
    Report Date
    November 18, 2011
    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 FOR THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT A SAMPLE OF A (B)(6) FEMALE YIELDED A POSITIVE REACTION WITH CELL 10 AND 11 OF BIOTESTCELL I11 IN ORTHO GEL CARDS. THE CUSTOMER ASKED WHETHER CELLS WERE TYPED FOR CERTAIN HLA ANTIGENS LIKE BGA . THE CUSTOMER HAD RETURNED PATIENT SAMPLE, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT. OUR QUALITY CONTROL LABORATORY TESTED THIS SAMPLE WITH THE RETAINED SAMPLE OF BIOTESTCELL I11 USING THE TUBE TECHNIQUE. THE SAMPLE REACTED NEGATIVELY WITH ALL CELLS OF BIOTESTCELL I11 EXCEPT FOR CELL 10. THE SAMPLE SHOWED A WEAK POSITIVE REACTION WITH CELL 10 OF BIOTESTCELL I11. FURTHER TESTING WITH SCREENING CELLS AT AN EXTENDED INCUBATION TIME AT 4 DEGREES C (WHICH IS NOT ACCORDING THE INSTRUCTION FOR USE) SHOWED POSITIVE REACTIONS. THIS TEST RESULT SUGGESTS FOR A COLD REACTING ANTIBODY. FURTHERMORE OUR QUALITY CONTROL LABORATORY TESTED THE SAMPLE OF THE (B)(6) FEMALE FOR HLA ANTIBODIES: THE RESULT WAS A MULTISPECIFIC ANTIBODY, 88 % OF THE PANEL CELLS REACTED POSITIVELY. DUE TO THE FACT THAT IT IS NOT REQUIRED THE DONORS OF BIOTESTCELL I11 WERE NOT TYPED FOR CERTAIN HLA ANTIGENS LIKE BGA. THE GEL CARD SYSTEM IS NOT SUITABLE FOR THE CUSTOMER'S INTENDED APPLICATION: DETECTION OF UNEXPECTED ANTIBODIES. IN THIS CASE, WE RECOMMEND THE TUBE TEST AND SOLID PHASE TEST SOLIDSCREEN II WITH TANGO OPTIMO. TESTING BY THE QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL I11 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE HAVE NO FURTHER COMPLAINTS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL- I11 BIOTESTCELL -I11 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8137011

    Patients

    Seq Age Sex Outcome Treatment
    1 ORTHO GEL CARD, LOT 050611001, EXP. 03/30/2012| BIOTESTCELL 1,2, LOT 8139011, EXP. 11/15/2011