BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS RUBELLA IGG

    MDR report key: 2073501 · Received May 2, 2011

    Report

    Report Number
    2122870-2011-01172
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LFX
    PMA / PMN Number
    K954687
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE DILUENT A AND S0 CALIBRATOR WERE TESTED AND DID NOT MEET ASSAY PERFORMANCE CRITERIA LINEARITY SPECIFICATION. THIS EVENT WILL BE FURTHER EVALUATED AND INVESTIGATED. NOTE: THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW ON (B)(6) 2011 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A LINEARITY STUDY WAS PERFORMED AT BECKMAN COULTER INC., (BCI) ON RUBELLA IGG ASSAY TO VERIFY USE OF WASH BUFFER II (WB II) AS A DILUENT. WB II, SAMPLE DILUENT A, AND S0 CALIBRATORS WERE PROCESSED DURING AN INTERNAL DXI ONBOARD DILUTION LINEARITY STUDY TO QUALIFY WB II AS AN ADDITIONAL ASSAY DILUENT. WB II, SAMPLE DILUENT, AND S0 CALIBRATORS DID NOT MEET THE ASSAY PERFORMANCE CRITERIA LINEARITY SPECIFICATIONS. NO PATIENT RESULTS WERE GENERATED IN THIS EVENT. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS RUBELLA IGG ACCESS RUBELLA IGG LFX BECKMAN COULTER INC. NA 910219

    Patients

    Seq Age Sex Outcome Treatment
    1