BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1 & 2

    MDR report key: 2341609 · Received November 18, 2011

    Report

    Report Number
    9610824-2011-00165
    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 1 OF BIOTESTCELL 1&2 IN ORTHO GEL CARDS. THE CUSTOMER ASKED WHETHER CELL 1 OF BIOTESTCELL 1&2 WAS TYPED FOR CERTAIN HLA ANTIGENS LIKE BGA . THE CUSTOMER HAD RETURNED THE PATIENT SAMPLE BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT. OUR QUALITY CONTROL LABORATORY TESTED THIS SAMPLE WITH THE RETAINED SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT BIOTESTCELL 1&2 USING THE TUBE TECHNIQUE. THE SAMPLE SHOWED WEAK POSITIVE REACTIONS WITH CELL 1 OF BIOTESTCELL 1&2. FURTHER TESTING AT AN EXTENDED INCUBATION TIME AT 4 °C (WHICH IS NOT ACCORDING THE INSTRUCTION FOR USE) SHOWED POSITIVE REACTIONS WITH BOTH CELLS OF BIOTESTCELL 1 &2. THIS TEST RESULT SUGGESTS A COLD REACTING ANTIBODY. ADDITIONALLY THE RETAINED SAMPLE BIOTESTCELL 1&2 WAS TESTED WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. 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 1&2 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 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 1 & 2 BIOTESTCELL 1 & 2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8139011

    Patients

    Seq Age Sex Outcome Treatment
    1 ORTHO GEL CARD, LOT 050611001, EXP. 03/30/12| BIOTESTCELL I-11, LOT 8137011, EXP. 11/01/2011