BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS THYROGLOBULIN ANTIBODY II REAGENT

    MDR report key: 4766219 · Received May 12, 2015

    Report

    Report Number
    2122870-2015-00284
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JNL
    PMA / PMN Number
    K062516
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NAME OF THE ESTABLISHMENT IS THE (B)(6). SERVICE WAS NOT DISPATCHED. CALIBRATION PASSED ON APRIL 3, 2015 WITH ACCESS THYROGLOBULIN ANTIBODY II REAGENT LOT 431463 AND CALIBRATOR LOT 435844. THERE IS NO EVIDENCE OF PRE-ANALYTICAL SAMPLE HANDLING ISSUE AND NO INDICATION THAT THE ACCESS THYROGLOBULIN ANTIBODY II REAGENT WAS RETURNED FOR EVALUATION. 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 TWO (2) OTHER METHODOLOGIES. THE CUSTOMER ANALYZED THE PATIENT'S SAMPLE ON AN ALTERNATE METHODOLOGY (ROCHE) AND OBTAINED A DISCORDANT, HIGHER RESULT ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THE CUSTOMER ALSO ANALYZED THE PATIENT'S SAMPLE ON A SECOND METHODOLOGY (SIEMENS) AND AGAIN 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. ASSAY CALIBRATION WAS PERFORMING WITHIN PUBLISHED SPECIFICATIONS. QC (QUALITY CONTROL) AND SYSTEM CHECK DATA WAS NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER DID NOT SUPPLY INFORMATION REGARDING SAMPLE COLLECTION SUCH AS TUBE TYPE. THE PATIENT'S SAMPLE WAS CENTRIFUGED FOR TEN (10) MINUTES AT 3,000 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
    308831 ACCESS THYROGLOBULIN ANTIBODY II REAGENT IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY JNL BECKMAN COULTER NA 431463

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR