BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS FREE T3 REAGENT

    MDR report key: 5004846 · Received August 14, 2015

    Report

    Report Number
    8020879-2015-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 16, 2015
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    CDP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY ANY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX OR WEIGHT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE IS NO EVIDENCE THAT THE ACCESS FT3 REAGENT WAS RETURNED FOR EVALUATION. IN CONCLUSION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 8020879-2015-00002, 8020879-2015-00004.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A REPRODUCIBLE, ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULT FOR ONE (1) PATIENT ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WAS DISCORDANT TO ANOTHER METHODOLOGY AND THE PATIENT'S OTHER THYROID FUNCTION TESTS. THE PATIENT'S FREE THYROXINE (ACCESS FRT4) RESULT AND THE PATIENT'S HUMAN THYROID-STIMULATING HORMONE (ACCESS HTSH) RESULT WERE WITHIN NORMAL REFERENCE RANGES. THE PATIENT'S SAMPLE WAS REANALYZED ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND ANOTHER ACCESS FREE T3 RESULT ABOVE THE CUSTOMER'S ESTABLISHED NORMAL REFERENCE RANGE WAS OBTAINED. THE CUSTOMER ALSO ANALYZED THE PATIENT'S SAMPLE ON AN ALTERNATE METHODOLOGY (CENTAUR, SIEMENS) AND OBTAINED A DISCORDANT, LOWER RESULT WITHIN THAT ASSAY'S NORMAL REFERENCE RANGE. THE ACCESS FREE T3 RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QC (QUALITY CONTROL) AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT SUPPLY CALIBRATION DATA. THE PATIENT'S SAMPLE WAS COLLECTED IN A BECTON DICKSON VACUTAINER SERUM SEPARATOR TUBE AND THEN CENTRIFUGED FOR FIFTEEN (15) MINUTES AT 3500 RPM (REVOLUTIONS PER MINUTE) AT ROOM TEMPERATURE. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539127 ACCESS FREE T3 REAGENT RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP BECKMAN COULTER IRELAND NA 570023

    Patients

    Seq Age Sex Outcome Treatment
    1