BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2547399 · Received April 25, 2012

    Report

    Report Number
    9610824-2012-00064
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 25, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 A FALSE NEGATIVE ANTIBODY SCREENING TEST OF A PATIENT WITH A KNOWN ANTI-E AND ANTI-K ON TANGO. THE IDENTIFICATION OF THE ANTIBODIES WAS PERFORMED USING THE ORTHO GEL SYSTEM. THE PATIENT SAMPLE THAT HAD CAUSED THE ALLEGEDLY FALSE NEGATIVE TEST RESULT WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF BIOTESTCELL 3 WITH THE PROVIDED PATIENT SAMPLE. THE SAMPLE REACTED NEGATIVELY. IN FURTHER TESTINGS THE PATIENT SAMPLE SHOWED A POSITIVE DIRECT ANTIGLOBULIN TEST (DAT) AND A VERY WEAK POSITIVE REACTION (+/- ) IN THE GEL METHOD. THE PATIENT MATERIAL WAS NOT SUFFICIENT TO CARRY OUT FURTHER TESTINGS. THE RETAINED SAMPLE OF BIOTESTCELL 3 WAS TESTED WITH DIFFERENT ANTIBODIES, INCLUSIVE AN ANTI-K AND ANTI-E. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. A CHECK-UP OF THE AFFECTED TANGO OPTIMO GAVE NO INSTIGATION TO SUSPECT THE PERFORMANCE OF THE DEVICE TO BE PART OF THE REPORTED PROBLEM.

    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 8207011

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLIDSCREEN II STRIP, LOT 8137050| ERYTYPECELL A1,B, LOT 8207011| ANTI-HUMAN-GLOBULIN, LOT 812112004| ERYTYPE S, LOT 8123010| BROMELIN, LOT 815105SS| TANGO OPTIMO, NO. (B)(4)| MLB2, LOT 8114021