BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 21749126 · Received April 1, 2025

    Report

    Report Number
    9612296-2025-00663
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    UDI-DI
    14987666540725
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE AU680 CLINICAL CHEMISTRY ANALYZER. THE FSE INSPECTED THE ANALYZER AND OBSERVED THAT ISE CALIBRATION VALUES WERE LOW AND OBSERVED BUBBLES ON THE INSTRUMENT. THE FSE READJUSTED THE J NOZZLES AS PART OF TROUBLESHOOTING MEASURE. THE FSE DETERMINED MULTIPLE HARDWARE MALFUNCTIONED. THE FSE REPLACED THE ISE (ION SELECTIVE ELECTRODE) BUFFER VALVE AND REAGENT (R) SYRINGE TO RESOLVE THE ISSUE. DUE TO MULTIPLE INTERVENTIONS PERFORMED, A SPECIFIC PART CANNOT BE IDENTIFIED AS THE SOLE CONTRIBUTOR OF THIS EVENT. A FAILURE OF ONE OR MORE OF THE REPLACED COMPONENTS OR A COMBINATION THEREOF IS THE LIKELY CAUSE OF THIS EVENT. THE FSE PERFORMED SYSTEM VERIFICATION SUCCESSFULLY WITHOUT ISSUES. THE SYSTEM RETURNED TO NORMAL OPERATION. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER IDENTIFIER IS CASE -(B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED GENERATION OF FALSE ISE PATIENT RESULTS WHICH INCLUDED SODIUM (NA) AND POTASSIUM (K) WITH "J" AND "K" FLAGS INVOLVING THE AU680 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT. THE CUSTOMER PROVIDED PATIENT DATA FOR THREE (3) PATIENTS. NOTE: PER BECKMAN COULTER AU680 CHEMISTRY ANALYZER USER GUIDE PNB04779AB, CHAPTER 7, FLAGS "J" FLAG REPRESENTS RESULT IS HIGHER THAN REPEAT DECISION RANGE. "K" FLAG REPRESENTS RESULT IS LOWER THAN THE REPEAT DECISION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624334 AU680 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE 14987666540725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown