BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS THYROGLOBULIN ANTIBODY II REAGENT

    MDR report key: 4953539 · Received July 30, 2015

    Report

    Report Number
    2122870-2015-00458
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 2, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JNL
    PMA / PMN Number
    K062516
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 THYROGLOBULIN ANTIBODY II REAGENT WAS RETURNED FOR EVALUATION. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO BECKMAN COULTER WHERE TESTING WAS PERFORMED TO EVALUATE THE SAMPLE FOR INTERFERENCE. NO INTERFERENCE WAS FOUND. THE SAMPLE WAS ALSO WAS ANALYZED ON A SECOND METHODOLOGY ((B)(4)) AND RECOVERED WITH A RESULT ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. IN CONCLUSION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A NORMAL THYROGLOBULIN ANTIBODY (ACCESS THYROGLOBULIN ANTIBODY II) RESULT FOR ONE (1) PATIENT ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WAS DISCORDANT TO ANOTHER METHODOLOGY. THE INITIAL ACCESS THYROGLOBULIN ANTIBODY II RESULT WAS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE CUSTOMER ANALYZED THE PATIENT'S SAMPLE ON AN ALTERNATE METHODOLOGY ((B)(4)) AND OBTAINED A DISCORDANT, HIGHER RESULT ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THE ACCESS THYROGLOBULIN ANTIBODY II RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER (BEC) CF ORIGINATOR RECOMMENDED THAT THE CUSTOMER PROVIDE THE PATIENT SAMPLE FOR TESTING BY THE BEC COMPLAINT HANDLING UNIT (CHU). CALIBRATION, QC (QUALITY CONTROL) AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. INFORMATION ON THE COLLECTION AND CENTRIFUGATION OF THE PATIENT SAMPLE WAS NOT SUPPLIED. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498665 ACCESS THYROGLOBULIN ANTIBODY II REAGENT IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY JNL BECKMAN COULTER 438550

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR