BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL P1 & P2

    MDR report key: 2287262 · Received October 12, 2011

    Report

    Report Number
    9610824-2011-00144
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Report Date
    October 12, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 WITH A KNOWN ANTIBODY CW YIELDED A FALSE NEGATIVE REACTION WITH CELL 1 OF BIOTESTCELL P1, P2. A TEST DATE WAS NOT AVAILABLE UPON REQUEST. THE SAMPLE THAT HAD CAUSED FALSE POSITIVES WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THE CUSTOMER HAD TESTED THE SAMPLE USING THE ORTHO GEL METHOD. THIS METHOD IS NOT ACCORDING TO THE INSTRUCTION FOR USE OF BIOTESTCELL P1, P2 AND NOT SUITABLE FOR THE CUSTOMER'S INTENDED APPLICATION: DETECTION OF UNEXPECTED ANTIBODIES. VALIDATING THE TEST METHOD IS THE USER'S RESPONSIBILITY AS IS CHOOSING AN APPROPRIATE TEST METHOD. ACCORDING TO THE INSTRUCTION FOR USE BIOTESTCELL P1, P1 IS SUITED FOR THE TUBE TECHNIQUE AND SOLIDSCREEN. IN OUR QUALITY CONTROL LABORATORY THE SAMPLE WAS RE-TESTED WITH THE RETAINED SAMPLE OF BIOTESTCELL P1, P2 USING THE TUBE TECHNIQUE, THE DIAMED GEL SYSTEM AND SOLIDSCREEN ON TANGO. THE SAMPLE REACTED NEGATIVELY IN THE TUBE TECHNIQUE, WEAK POSITIVELY WITH THE DIAMED GELSYSTEM AND STRONG POSITIVELY IN SOLIDSCREEN. TESTING BY QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL P1, P2 FUNCTIONS CORRECTLY. A DETERMINATION OF THE ANTIBODY CW DEPENDED ON THE METHOD USED. 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 P1 & P2 BIOTESTCELL P1, P2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2133011

    Patients

    Seq Age Sex Outcome Treatment
    1