BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2710624 · Received August 23, 2012

    Report

    Report Number
    9610824-2012-00127
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Date of Event
    July 26, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ANTIBODY SCREENING TESTS WITH BIOTESTCELL 3. THE CUSTOMER HAD NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY IS STILL TESTING THE RETAINED SAMPLE OF BIOTESTCELL 3 WITH DIFFERENT SAMPLES AND CONTROLS. AS SOON AS WE WILL GET TEST RESULTS, WE WILL SEND IN OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ANTIBODY SCREENING TESTS WITH BIOTESTCELL 3 IN THE ORTHO GEL SYSTEM. THE CUSTOMER REPORTED THAT THE ANTIBODY SCREENING TESTS WERE CORRECTLY NEGATIVE WHEN HE REPEATED THE TESTING WITH FRESHLY PREPARED CELL SUSPENSIONS ACCORDING THE INSTRUCTION FOR USE FOR GEL SYSTEM. THE CUSTOMER HAS RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT. BUT AT THAT TIME THE SUPPOSEDLY DEFECTIVE PRODUCT HAS ALREADY BEEN EXPIRED. THEREFORE A JUDICIOUS TESTING IN OUR QUALITY CONTROL LABORATORY WAS NOT POSSIBLE. 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 SOLIDPHASE TEST SOLIDSCREEN WITH TANGO OPTIMO. THIS COMPLAINT WAS CAUSED BY A CUSTOMER'S HANDLING ERROR. 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 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8227021

    Patients

    Seq Age Sex Outcome Treatment
    1