BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 2580777 · Received May 21, 2012

    Report

    Report Number
    9610824-2012-00076
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 21, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 #2 OF BIOTESTCELL 1&2, YIELDED FALSE POSITIVE ANTIBODY SCREENING TEST RESULTS IN THE TUBE TECHNIQUE AND THE ORTHO GEL METHODOLOGY. THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED, BUT NONE OF THE PATIENT SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THE SUPPOSEDLY DEFECTIVE PRODUCT WITH DIFFERENT DONOR SAMPLES, AND POSITIVE AND NEGATIVE CONTROLS IN SOLIDSCREEN II ON TANGO AND IN THE TUBE TECHNIQUE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. 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 OUR 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 8211011

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL-I11, LOT 8213011, EXP. 05/15/2012| BIOTESTCELL-I11 PLUS, LOT 8211011, EXP. 05/01/2012