BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CHEMISTRY ANALYZER WITH ISE, EUROPE, 230V

    MDR report key: 2506474 · Received March 27, 2012

    Report

    Report Number
    2050012-2012-00784
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INCUBATOR TEMPERATURE CONTROLLER BOARD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED AMMONIA AND C-REATIVE PROTEIN (CRP) RESULTS FROM THE AU680 CHEMISTRY ANALYZER FOR TWO PATIENTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED ACCEPTABLE RESULTS. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QC BEFORE AND AFTER THE EVENT WAS WITHIN THE SPECIFICATIONS. NO ERROR CODES OR FLAGS WERE GENERATED WITH THE ERRONEOUS RESULTS. FIELD SERVICE ENGINEER (FSE) HAD BEEN ONSITE PREVIOUSLY TO REPLACE DEIONIZED WATER AND WASH TEMPERATURE CONTROL BOARDS, AND THERMISTOR. THE FSE INDICATED THAT THE FACILITY TEMPERATURE VARIES GREATLY THROUGHOUT THE DAY. ONE EXAMPLE NOTED WAS THAT AMBIENT LAB TEMPERATURE WAS 20°C IN THE MORNING BUT WAS UP AROUND 27°C BY THE AFTERNOON. BEC LABELING DIRECTS THAT NO MORE THAN A ± 2°C TEMPERATURE SHOULD BE ALLOWED DURING SYSTEM MEASUREMENT MODE. HOTLINE REVIEW OF THE REACTION CURVES SUGGESTED THAT ONE POSSIBLE FAILURE MODE COULD BE A CUVETTE OVERFLOW SITUATION. FURTHER INVESTIGATION REVEALED THAT THE CUSTOMER NEGLECTED TO RECALIBRATE CRP FOLLOWING THE ORIGINAL PCBS AND THERMISTOR CHANGES. BEC LABELING REQUIRES ASSAYS TO BE RECALIBRATED FOLLOWING ANY MAJOR PARTS REPLACEMENT. SERVICE WAS DISPATCHED. THE FSE INDICATED THAT THIS WAS NOT A TRUE CUVETTE OVERFLOW, BUT MORE OF MOISTURE BUILD UP OR FOG ON THE CUVETTES DUE TO THE FAILURE OF THE INCUBATOR TEMPERATURE CONTROLLER BOARD. THE CAUSE OF THE EVENT WAS FAULTY INCUBATOR TEMPERATURE CONTROLLER BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU680 CHEMISTRY ANALYZER WITH ISE, EUROPE, 230V CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU681-03E NA

    Patients

    Seq Age Sex Outcome Treatment
    1