BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2680362 · Received December 15, 2010

    Report

    Report Number
    9610824-2010-00017
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT AN ANTI-E DIDN'T REACT POSITIVE WITH BIOTESTCELL P3 ART (B)(4), LOT 7039021 ON TANGO. THE CUSTOMER HAS SENT US THE AFFECTED SAMPLE. THE COMPLAINT PRODUCT BIOTESTCELL P3 WAS NOT SENT. THEREFORE THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE OF THE COMPLAINED LOT BIOTESTCELL P3 IN COMBINATION WITH THE SAMPLE ON TANGO. WE COULD CONFIRM A NEGATIVE REACTION OF THE SAMPLE WITH CELL 2 OF BIOTESTCELL P3. THE USED POSITIVE AND NEGATIVE CONTROL REACTED CORRECTLY AND CLEARLY POSITIVE RESPECTIVELY NEGATIVE. FURTHER TESTING IN THE DIAMED GEL SYSTEM SHOWED NEGATIVE REACTIONS IN THE LISS/ COOMBS TECHNIQUE. THE THREE PHASE TESTING IN THE TUBE TECHNIQUE SHOWED NEGATIVE REACTIONS AT ROOM TEMPERATURE AND AT 37 DEGREES CELSIUS. IN THE INDIRECT ANTI-HUMAN GLOBULIN TEST ONLY A +/- REACTION WAS OBSERVED. THE ENZYME TEST WITH BROMELAIN SHOWED A 1+ POSITIVE REACTION WITH THE E POSITIVE CELL. ON TANGO THE E POSITIVE ENZYME TREATED RED CELL REACTED STRONGLY POSITIVE. THE TESTS CARRIED OUT SHOW THAT THIS ANTIBODY (ANTI-E) IS A VERY WEAK REACTING ANTIBODY AND PREFERENTIALLY REACTING IN THE ENZYME TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7039021

    Patients

    Seq Age Sex Outcome Treatment
    1 MLB2: LOT 70131110| ORTHO ANTI-IGG: LOT 072710001, (EXP. 05/26/2011)| ORTHO SURGISCREEN: LOT VSS340, (EXP. 11/16/2010)| SOLIDSCREEN II PLATE: LOT 7010010| AHG: LOT 79491300