BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS FREE T3 REAGENT

    MDR report key: 5513618 · Received March 21, 2016

    Report

    Report Number
    8020879-2016-00015
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Date of Event
    November 11, 2015
    Report Date
    March 1, 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
    UK
    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. THE REAGENT LOT NUMBER WAS NOT PROVIDED. THE MANUFACTURING DATE AND EXPIRATION DATE COULD NOT BE DETERMINED. (B)(6). 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 FREE T3 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: 8020879-2016-00014, 8020879-2016-00015, 8020879-2016-00016, 8020879-2016-00017, 8020879-2016-00018, 8020879-2016-00019. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULTS FOR TWO PATIENTS ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WERE DISCORDANT TO ANOTHER METHODOLOGY AND THE PATIENT'S CLINICAL FILE. FOR ONE PATIENT, THE FREE THYROXIN (ACCESS FREE T4) AND THE HUMAN THYROID-STIMULATING HORMONE (ACCESS HTSH) RESULTS WERE WITHIN NORMAL REFERENCE RANGES. FOR THE SECOND PATIENT, THE FREE THYROXIN (ACCESS FREE T4) RESULT WAS ABOVE THE NORMAL REFERENCE RANGE AND THE HUMAN THYROID-STIMULATING HORMONE (ACCESS HTSH) RESULT WAS WITHIN NORMAL REFERENCE RANGE.THE CUSTOMER ALSO ANALYZED THE PATIENTS SAMPLES ON AN ALTERNATE METHODOLOGY (E602, ROCHE) AND OBTAINED DISCORDANT, LOWER FREE TRIIODOTHYRONINE RESULTS WITHIN THAT ASSAY'S NORMAL REFERENCE RANGE. THE ACCESS FREE T3 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGES IN PATIENT TREATMENTS ASSOCIATED WITH THIS EVENT. THIS MDR ADDRESSED THE RESULTS OBTAINED FOR TWO PATIENTS ON (B)(6) 2015, 8020879-2016-00014 WILL ADDRESS THE RESULTS OBTAINED ON (B)(6) 2015, 8020879-2016-00016 WILL ADDRESS THE RESULTS OBTAINED ON (B)(6) 2015, 8020879-2016-00017 WILL ADDRESS THE RESULTS OBTAINED ON (B)(6) 2015, 8020879-2016-00018 WILL ADDRESS THE RESULTS OBTAINED ON (B)(6) 2015, AND 8020879-2016-00019 WILL ADDRESS THE RESULTS OBTAINED ON (B)(6) 2016. CALIBRATION, QC 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. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170055 ACCESS FREE T3 REAGENT RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP BECKMAN COULTER IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1