BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 22946016 · Received September 2, 2025

    Report

    Report Number
    2122870-2025-00094
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ACCESS HSTNI (ACCESS HIGH SENSITIVITY TROPONIN I, REAGENT PART NUMBER B52699 LOT 440548) PATIENT RESULTS ON THEIR DXI 600 INSTRUMENTS (PART NUMBER A71460 SERIAL NUMBER (S/N) (B)(6)). THE CUSTOMER REPORTED THAT THE FOLLOWING HSTNI RESULTS WERE OBTAINED FOR ONE PATIENT: O 3.20 NG/L ON (B)(6) 2025 (2:36 AM) ON DXI 600 S/N (B)(6). O 17643.12 NG/L ON (B)(6) 2025 (4:05 AM) ON DXI 600 S/N (B)(6). - INITIAL QUESTIONED RESULT WHICH LEAD TO A CHANGE IN THE PATIENT'S TREATMENT O 3.63 NG/L ON (B)(6) 2025 (7:17 AM) ON DXI 600 S/N (B)(6). O 681.18 NG/L ON (B)(6) 2025 (9:11 AM) ON DXI 600 S/N (B)(6). O 2.88 NG/L ON (B)(6) 2025 (9:33 AM) ON DXI 600 S/N (B)(6). O 2.94 NG/L ON (B)(6) 2025 (9:33 AM) ON DXI 600 S/N (B)(6). O 3.03 NG/L ON (B)(6) 2025 (9:34 AM) ON DXI 600 S/N (B)(6). O 2.97 NG/L ON (B)(6) 2025 (9:44 AM) ON DXI 600 S/N (B)(6). O 3.52 NG/L ON (B)(6) 2025 (9:48 AM) ON DXI 600 S/N (B)(6). THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT A CHANGE TO MEDICAL TREATMENT AS A CAUSE OF THIS EVENT. A HEPARIN DRIP WAS ADMINISTERED TO THE PATIENT. THERE WAS NO REPORT OF FURTHER IMPACT TO THE PATIENT AS A RESULT OF THE CHANGE IN TREATMENT. NO OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. FOR INSTRUMENT S/N (B)(6): · SYSTEM CHECK ON (B)(6) 2025 INITIALLY FAILED FOR WASH EFFICIENCY AND SUBSTRATE WASHED RATIO HOWEVER PASSED WHEN REPERFORMED. · CALIBRATION PASSED ON (B)(6) 2025 WITH REAGENT LOT 440548 AND CALIBRATOR LOT 538097. · QUALITY CONTROL (QC) WERE WITHIN LABORATORY¿S EXPECTED RANGES WHEN THE EVENT OCCURRED. LEVEL 1A QC WAS ON THE HIGHER SIDE OF THE RANGE. · PRECISION TESTING WAS PERFORMED AND PASSED, CONFIRMING ACCEPTABLE INSTRUMENT PERFORMANCE. THE CUSTOMER REPORTED ONGOING PERISTALTIC PUMP AND DISPENSE PROBE PLATE MOTION ERRORS, THE DAY OF THE ERRONEOUS HSTNI RESULT. FOR INSTRUMENT S/N (B)(6): NO HARDWARE ISSUE WAS OBSERVED ON DXI 600 INSTRUMENT S/N (B)(6). CALIBRATION PASSED ON (B)(6) 2025 WITH REAGENT LOT 538289 AND CALIBRATOR LOT 440395. QC WERE WITHIN LABORATORY¿S ESTABLISHED RANGE ON (B)(6) 2025. QC WERE NOT PERFORMED ON (B)(6) 2025. A PRECISION TEST WITH TWO DIFFERENT QC LOTS WAS PERFORMED AND PASSED. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLES WERE COLLECTED IN GOLD TOP TUBES AND CENTRIFUGATED FOR 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018237 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER INC. 440548 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other