BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS(R) THYROXINE ASSAY CALIBRATOR

    MDR report key: 2322891 · Received November 3, 2011

    Report

    Report Number
    2122870-2011-05067
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KLI
    PMA / PMN Number
    K926475
    Removal / Correction Number
    Z-3027-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER NOTIFICATION AND REPLACEMENT ACTION WAS INITIATED BY BECKMAN COULTER INC. FOR THE SUSPECT CALIBRATOR LOT INVOLVED IN THIS EVENT. THE ROOT CAUSE OF THE CALIBRATOR ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS TOTAL THYROXINE (TT4) RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS IN ASSOCIATION WITH THE USE OF A SPECIFIC ACCESS(R) THYROXINE ASSAY CALIBRATOR LOT. THE INITIAL TT4 RESULTS WERE ASSOCIATED WITH ACCESS(R) THYROXINE ASSAY CALIBRATOR LOT NUMBER 024072. UPON REPLACEMENT OF THIS CALIBRATOR LOT WITH A NEW LOT, A SELECT NUMBER OF THE INITIAL PATIENT SAMPLES WERE RETESTED AND A 20-25% INCREASE IN DOSE VALUE WAS NOTED. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATES THE INVOLVEMENT OF TWELVE PATIENT RESULTS. THE INITIAL RESULTS WERE EITHER BELOW OR WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. UPON REPEAT TESTING OF THREE PATIENT SAMPLES AFTER RECALIBRATION WITH A NEW CALIBRATOR LOT, ALL THREE RESULTS WERE HIGHER. THE INITIAL TT4 RESULTS WERE RELEASED FROM THE LABORATORY; HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA INDICATED THAT QUALITY CONTROL RESULTS RECOVERED GREATER THAN TWO STANDARD DEVIATIONS BELOW THE MEAN VALUE WHEN UTILIZING THE SUSPECT CALIBRATOR LOT. THE TT4 SAMPLES WERE SERUM SAMPLES DRAWN IN 13X100, YELLOW CAP TUBES. THE CUSTOMER INDICATED THAT THE SAMPLES WERE TESTED IN ALIQUOT TUBES. THE CUSTOMER COULD NOT VERIFY IF THE SAMPLES WERE FULL DRAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS(R) THYROXINE ASSAY CALIBRATOR ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE KLI BECKMAN COULTER, INC. NA 024072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM