BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL T4 CALIBRATOR

    MDR report key: 2395851 · Received January 3, 2012

    Report

    Report Number
    2122870-2012-00006
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 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
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THROUGH BECKMAN COULTER INC. INVESTIGATION IT WAS IDENTIFIED THAT CALIBRATOR LOT 120301 WAS EXPECTED TO DEMONSTRATE A SHIFT UP IN QUALITY CONTROL AND PATIENT RECOVERY OF APPROXIMATELY TWO TO FOURTEEN PERCENT. THIS LOT MET ALL INTERNAL SPECIFICATIONS PRIOR TO RELEASE AND WAS WITHIN THE NORMAL ASSAY VARIABILITY. THE OTHER TT4 CALIBRATOR LOT ASSOCIATED WITH THIS EVENT (LOT 021654) WAS IDENTIFIED AS THE ROOT CAUSE FOR FALSELY DECREASED TOTAL T4 PATIENT OR QUALITY CONTROL RESULTS OF UP TO TWO STANDARD DEVIATIONS OR MORE IN A PREVIOUS BECKMAN COULTER INC. INVESTIGATION. THIS IS A KNOWN ISSUE FOR WHICH CUSTOMER NOTIFICATION WAS GENERATED, PROVIDED AND DISCUSSED WITH THIS CUSTOMER BY BECKMAN COULTER INC. BECKMAN COULTER INC. RECORDS INDICATE THAT THE CUSTOMER HAD NOT RETURNED THE ASSOCIATED NOTIFICATION FAXBACK FORM TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2011 TOTAL T4 (TT4) QUALITY CONTROL (QC) RESULTS FAILED TO MEET CUSTOMER ESTABLISHED SPECIFICATIONS. THE QC SHIFT TO UNACCEPTABLE RESULTS COINCIDED WITH TRANSITION FROM CALIBRATOR LOT 021654 TO CALIBRATOR LOT 120301. PATIENT RESULTS USING CALIBRATOR LOT 021654 WERE REPORTED OUT OF THE LABORATORY. THE QUANTITY, ACTUAL RESULTS AND EVENT DATES ASSOCIATED WITH PREVIOUSLY REPORTED PATIENT RESULTS ASSOCIATED WITH TOTAL T4 (TT4) CALIBRATOR LOT 021654 IS UNKNOWN. WHILE THERE WERE NO REPORTS OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN AS TO WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. NO PATIENT INFORMATION, ACTUAL PATIENT RESULTS OR SAMPLE RELATED INFORMATION WAS PROVIDED FOR THIS EVENT. NO ADDITIONAL SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS TOTAL T4 CALIBRATOR ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE KLI BECKMAN COULTER, INC. NA 021654

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS 2 IMMUNOASSAY SYSTEM