BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS THYROGLOBULIN ANTIBODY II

    MDR report key: 2074294 · Received May 2, 2011

    Report

    Report Number
    2122870-2011-01239
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JNL
    PMA / PMN Number
    K062516
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE FURTHER EVALUATED AND INVESTIGATED. NOTE: THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW ON 04/01/2011 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS CF IS RELATED TO (B)(4).

    Description of Event or Problem · 1

    THIS CF WAS OPENED TO CAPTURE FURTHER EVALUATION OF THYROGLOBULIN ANTIBODY ASSAY (THGABY) NOT MEETING LINEARITY SPECIFICATIONS. IN 2009, BECKMAN COULTER INC., (BCI) WAS PERFORMING INTERNAL DXI ONBOARD DILUTION LINEARITY STUDIES FOR MULTIPLE ASSAYS. WB II, SAMPLE DILUENT A, AND S0 CALIBRATORS WERE PROCESSED DURING THIS 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 THYROGLOBULIN ANTIBODY II ACCESS THYROGLOBULIN ANTIBODY II JNL BECKMAN COULTER INC. NA 831065

    Patients

    Seq Age Sex Outcome Treatment
    1