BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU681 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3850025 · Received June 4, 2014

    Report

    Report Number
    9612296-2014-00090
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND OBSERVED A WORN BUFFER SYRINGE AND REPLACED THE SYRINGE. AFTER PRIMING THE SYSTEM, THE FSE ATTEMPTED TWO CONSECUTIVE CALIBRATIONS BUT DID NOT PASS. IN ADDITION, AN MID STANDARD STABILITY ERRORS WERE OBTAINED. THE FSE NOTED THE CUSTOMER REPLACED THREE ELECTRODES, THE PINCH TUBING, ROLLER TUBES, AND REAGENTS. THE FSE THEN REPLACED THE REFERENCE ELECTRODE. THE FSE PERFORMED THREE CONSECUTIVE CALIBRATIONS SUCCESSFULLY. THE FSE ALSO COMPLETED A 20-REPETITION PRECISION TEST, USING L1 CONTROLS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, SYSTEM HARDWARE IS THE LIKELY CAUSE OF THE EVENT AS REPAIRS RESOLVED THE REPORTED ISSUE. HOWEVER, A SPECIFIC HARDWARE COMPONENT WAS NOT IDENTIFIED AS THE SINGULAR CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT, ELEVATED SODIUM (NA) AND CHLORIDE (CL) PATIENT RESULTS INVOLVING THE AU681 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER STATED NO ERRONEOUS PATIENT RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORMED SYSTEM DIAGNOSTICS AND REPLACED THE ELECTRODES BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER STATED THE SAMPLES WERE REANALYZED ON AN ALTERNATE AU681 CLINICAL CHEMISTRY ANALYZER AND NORMAL RESULTS WERE OBTAINED. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326666 AU681 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU681-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1