BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS TSH (3RD IS)

    MDR report key: 16315370 · Received February 7, 2023

    Report

    Report Number
    2122870-2023-00061
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 7, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLW
    UDI-DI
    15099590671495
    PMA / PMN Number
    K153651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PATIENT IDENTIFIER IS CASE(B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGHT, ETHNICITY OR RACE. THE ACCESS TSH (3RD IS) REAGENT WAS NOT RETURNED FOR EVALUATION. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. THERE WERE NO REPORTS OF HARDWARE ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS IN CONNECTION WITH THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH REVIEW OF CUSTOMER-SUPPLIED DATA SHOWS THE CUSTOMER'S BIO-RAD LEVEL 1 QC WAS OUTSIDE LOW 3SD ON (B)(6) 2023 IT WAS RUN ON (B)(6) 2023 AND PASSING RESULTS WERE OBTAINED. IN CONCLUSION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ON (B)(6) 2023 AN ERRONEOUS LOW TSH RESULT (ACCESS TSH, 3RD IS, PART NUMBER B63284 AND LOT NUMBER 234374) WAS GENERATED ON THE CUSTOMER'S ACCESS (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4). THE LOW TSH RESULT OF 0.068 UIU/ML RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE CLINICIAN STARTED A TREATMENT (TREATMENT DETAILS INCLUDING MEDICATION(S) AND DOSAGES NOT PROVIDED) FOR THE PATIENT. ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2023 AND WAS TESTED FOR TSH ON AN ALTERNATE PLATFORM (PLATFORM INFORMATION NOT PROVIDED); A RESULT OF 3.177 UIU/ML WAS OBTAINED. THERE WAS NO INFORMATION PROVIDED REGARDING POSSIBLE REPEAT TESTING OF THE ORIGINAL SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2023. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER'S BIO-RAD LEVEL 1 QC WAS OUTSIDE LOW OF THE 3SD RANGES ON (B)(6) 2023, THEN PASSED ON (B)(6) 2023. THERE WAS NO REPORT OF HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS AT THE TIME OF THE EVENT. SAMPLE COLLECTION AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, VOLUME COLLECTED, STORAGE AND HANDLING CONDITIONS, CENTRIFUGATION TIME AND SPEED AND OTHER SAMPLE HANDLING INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318199 ACCESS TSH (3RD IS) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW BECKMAN COULTER B63284 234374 15099590671495

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other