BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS FREE T3 REAGENT

    MDR report key: 5501576 · Received March 15, 2016

    Report

    Report Number
    8020879-2016-00011
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 22, 2016
    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

    (B)(6). A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS 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 FREE T3 REAGENT WAS RETURNED FOR EVALUATION. ONE SAMPLE WAS SENT TO THE BECKMAN COULTER COMPLAINT HANDLING UNIT. THE PATIENT SAMPLE WAS ANALYZED ON THE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4), AND RECOVERED WITH ACCESS FREE T3 RESULTS ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THIS RESULT CONFIRMED THE RESULT OBTAINED BY THE CUSTOMER. INTERFERENCE TESTING, USING GOAT IGG BLOCKER AND A BLOCKER RELATED TO ALKALINE PHOSPHATASE, WAS PERFORMED. THE SAMPLE RECOVERED SIMILARLY AND WITHIN THE ASSAY REFERENCE RANGE. THE INVESTIGATION COULD NOT DEMONSTRATE ANY INTERFERENCE. IN CONCLUSION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 8020879-2016-00013 .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULT FOR ONE PATIENT ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WAS DISCORDANT TO ANOTHER METHODOLOGY AND THE PATIENT'S CLINICAL FILE. THE SAMPLE WAS REPEATED AND A SIMILAR ELEVATED RESULT, ABOVE THE ASSAY'S NORMAL REFERENCE RANGE WAS OBTAINED. THE PATIENT'S FREE THYROXIN (ACCESS FREE T4) AND THE PATIENT'S HUMAN THYROID-STIMULATING HORMONE (ACCESS HTSH) RESULTS WERE WITHIN NORMAL REFERENCE RANGES. THE CUSTOMER ALSO ANALYZED THE PATIENT SAMPLE ON AN ALTERNATE METHODOLOGY (CENTAUR, SIEMENS) AND OBTAINED A DISCORDANT, LOWER FREE TRIIODOTHYRONINE RESULT WITHIN THAT ASSAY'S NORMAL REFERENCE RANGE. THE ACCESS FREE T3 RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS MDR ADDRESSES THE FIRST RESULT OBTAINED ON (B)(6) 2016. MDR 8020879-2016-00013 WILL ADDRESS THE SECOND RESULT OBTAINED ON (B)(6) 2016. CALIBRATION, QC AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A (B)(6) SERUM TUBE AND WAS CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR FIFTEEN (15) MINUTES AT ROOM TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158671 ACCESS FREE T3 REAGENT RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP BECKMAN COULTER IRELAND NA 570116

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR