BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS FREE T4

    MDR report key: 4215987 · Received October 31, 2014

    Report

    Report Number
    8020879-2014-00013
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    July 11, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    CEC
    PMA / PMN Number
    K982250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED TWO (2) PATIENT SAMPLES TO BECKMAN COULTER FOR INVESTIGATION. BECKMAN COULTER TESTED THE SAMPLES NEAT (UNDILUTED) FOLLOWING CENTRIFUGATION FOR THE FRT4 ASSAY AND OBTAINED ELEVATED FRT4 RESULTS WHICH MATCHED THE CUSTOMER'S RESULTS. BECKMAN COULTER ALSO PERFORMED AN INTERFERENCE TESTING USING A MIX OF DIFFERENT BLOCKERS AND THE TESTING DID NOT ALLOW TO DETECT INTERFERENCE SINCE NONE OF THE BLOCKERS USED WERE ABLE TO MODIFY THE SIGNAL. BECKMAN COULTER THEN PERFORMED AN ANTI-STREPTAVIDIN ANTIBODIES/BIOTIN DEPLETION TESTING. THE DEPLETION TESTING DID NOT ALLOW TO DETECT AN INTERFERENCE RELATED EITHER TO STREPRAVIDIN OR TO BIOTIN WITHIN THE PROVIDED PATIENT SAMPLES. BECKMAN COULTER'S INVESTIGATION COULD NOT DEMONSTRATE ANY INTERFERENCE AND THE CAUSE OF THE DISCORDANCE COULD NOT BE DETERMINED. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 8020879-2014-00012; 8020879-2014-00013.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ELEVATED FREE T4 (ACCESS FRT4) RESULTS, FOR ONE (1) PATIENT OVER MULTIPLE DAYS, INVOLVING THE UNICEL DXI ACCESS IMMUNOASSAY SYSTEM. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2014; PLEASE REFER TO MEDWATCH REPORT NUMBER 8020879-2014-00012 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2014. THE ELEVATED FRT4 RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PHYSICIAN PERFORMED A THYROIDECTOMY ON THE PATIENT ON (B)(6) 2014 BASED ON THE FRT4 RESULT AND BECAUSE THE PATIENT HAD TROUBLE SWALLOWING. THE ACCESS FRT4 REAGENT WAS USED IN CONJUNCTION WITH THE UNICEL DXI ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698792 ACCESS FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC BECKMAN COULTER NA 470064

    Patients

    Seq Age Sex Outcome Treatment
    1 Other