BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS THYROGLOBULIN

    MDR report key: 22787575 · Received August 12, 2025

    Report

    Report Number
    2122870-2025-00090
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JNL
    UDI-DI
    15099590227173
    PMA / PMN Number
    K112933
    Removal / Correction Number
    2050012-07/02/2025-025C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TG (ACCESS THYROGLOBULIN, PART NUMBER: 33860, LOT NUMBER: 439163) PATIENT RESULTS, GENERATED ON THEIR DXI 800 ANALYZERS (PART: A71456, SERIAL NUMBERS: (B)(6). THE CUSTOMER VERBALLY STATED THEY HAVE SEEN THIS ISSUE ONGOING SINCE ON (B)(6) 2025, HOWEVER, ONE PATIENT ON (B)(6) 2025 HAD THE FOLLOWING RESULTS GENERATED AND UNDERWENT A CHANGE TO TREATMENT: THE INITIAL RESULT FOR THIS PATIENT WAS 4.3 NG/ML ON (B)(6) 2025 ON DXI 800 SERIAL NUMBER (SN): (B)(6). THE PATIENT SAMPLE WAS SENT TO (B)(6) FOR TESTING ON THEIR DXI 800 WITH A RESULT OF < 0.1 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED ON BOTH THE INITIAL CUSTOMER INSTRUMENT, SN: (B)(6), AND THE CUSTOMER¿S OTHER DXI 800, SN: (B)(6) ON (B)(6) 2025. 609235 REPEAT RESULTS ¿ 4.6 AND 4.3 NG/ML. 609234 REPEAT RESULTS ¿ 4.2 AND 4.2 NG/ML. THE CUSTOMER REPORTED THIS PATIENT HAD ADDITIONAL SCANS PERFORMED WHICH WERE NEGATIVE FOR CANCER. A CT (COMPUTED TOMOGRAPHY) SCAN WITH 100 CC'S OF OMNIPAQUE 350 CONTRAST DYE AND A PET SCAN WITH 13.94 MCI OF F-18 FDG WERE PERFORMED. NO FURTHER INFORMATION REGARDING THE PATIENT TREATMENT WAS PROVIDED. THE PATIENT RESULTS WERE BELOW THE AMR (ASSAY MEASURING RANGE) WHEN THE PATIENT SAMPLES WERE RUN AT A REFERENCE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. FOR DXI 800 SN: (B)(6): SYSTEM CHECK PASSED 21MAY2025. A PASSING CALIBRATION CURVE WAS OBTAINED 2025-06-05 USING REAGENT LOT: 439163 AND CALIBRATOR LOT: 440169. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORIES ESTABLISHED RANGES AND SIMILAR TO JUNE PEER GROUP. FOR DXI 800 SN: (B)(6): SYSTEM CHECK PASSED 16APR2025. A PASSING CALIBRATION CURVE WAS OBTAINED 2025-05-26 USING REAGENT LOT: 439163 AND CALIBRATOR LOT: 440169 ON INSTRUMENT 609235. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORIES ESTABLISHED RANGES AND SIMILAR TO JUNE PEER GROUP. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350983 ACCESS THYROGLOBULIN IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY JNL BECKMAN COULTER, INC. 439163 15099590227173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other