BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1 & 2

    MDR report key: 2341592 · Received November 18, 2011

    Report

    Report Number
    9610824-2011-00167
    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
    NV, 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 SAMPLES YIELDED FALSE POSITIVE REACTIONS WITH BIOTESTCELL 1&2 IN ORTHO GEL CARDS. TESTING OCCURRED BETWEEN (B)(6). SINCE THE CUSTOMER WAS NOT ABLE TO PROVIDE EITHER EXACT TEST DATES NOR TEST RESULTS, WE DECIDED TO TAKE AS A DATE OF EVENT FOR THIS INCIDENT FOR THE DAY THE CUSTOMER CAME FORWARD REPORTED IT.THE CUSTOMER HAD RETURNED NEITHER PATIENT SAMPLES NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED DIFFERENT SAMPLES WITH THE RETAINED SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT BIOTESTCELL 1&2. ALL SAMPLES REACTED CORRECTLY NEGATIVELY WITH BOTH CELLS OF BIOTESTCELL 1&2. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. 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 FUNTIONS 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 0,8% PANEL C, LOT VRC159| ORTHO GEL CARD, LOT 091211001-16