BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 21428695 · Received February 20, 2025

    Report

    Report Number
    9612296-2025-00591
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 20, 2025
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    14987666543016
    PMA / PMN Number
    K112412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BECKMAN FIELD SERVICE ENGINEER (FSE) EVALUATED THE AU5800 CLINICAL CHEMISTRY ANALYZER AND FOUND THE SAMPLE PROBE WAS CLOGGED, WHICH WAS REPLACED TO RESOVLE THE ISSUE. THE FSE RESEATED THE CONNECTIONS BETWEEN THE CLOT DETECTION CIRCUIT BOARD AND THE DISPENSER CONTROL CIRCUIT BOARD. THE FSE PERFORMED VERIFICATION AND VERIFIED THE ANALYZER RESUMED TO NORMAL OPERATION. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. SECTION E1, INITIAL REPORTER TELEPHONE NUMBER IS (B)(6), THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBTAINING A SAMPLE CLOT DETECT ERRORS ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. AS A RESULT, TWO (2) PATIENTS HAD LOW RESULTS WITH G AND K FLAGS FOR ION SELECTIVE ELECTRODE (ISE) INCLUDING SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL). THE SAMPLES WERE REPEATED ON ANOTHER AU ANALYZER AND RESULTS WERE NORMAL. THE CUSTOMER DID NOT RELEASE THE INITIAL LOW RESULTS OUT OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENTS DEMOGRAPHICS. THE CUSTOMER PROVIDED THE RESULTS FOR TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666444 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5800-10 CHEMISTRY ANALYZER AU5800 N/A 14987666543016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown