BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU681-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2073437 · Received May 1, 2011

    Report

    Report Number
    2050012-2011-01381
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011 THE CUSTOMER RECEIVED SAMPLE PROBE CLOT DETECT ALARMS. QC WAS IN THE LAB'S RANGES ON (B)(6) 2011. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ADJUSTED PULSE CORRECTIONS FOR DEAD VOLUMES, AND VERIFIED SAMPLE PROBE ALIGNMENT. THE FSE REPLACED THE SAMPLE ARM ASSEMBLY DUE TO LEVEL SENSE ISSUES. ON THE NEXT DAY, THE SAMPLE PROBE WAS HITTING THE SIDE OF THE SAMPLE TUBES. THE FSE VERIFIED ALIGNMENTS, BUT FOUND THAT THE WRONG RACK TYPE WAS BEING USED. THE CUSTOMERS WERE TRAINED. A FEW DAYS LATER, THE FSE ADJUSTED THE MECHANICAL ALIGNMENT OF THE SAMPLE PROBE AND ALSO REALIGNED THE SAMPLER UNIT. THE PROBE WAS COMING CLOSE TO THE SIDE OF THE WASH STATION WHICH COULD HAVE CAUSED INTERMITTENT SHORTING OF LEVEL SENSE. THE FSE WATCHED SEVERAL SAMPLES WITHOUT NESTING CUPS SAMPLE PROPERLY. ROOT CAUSE FOR THE EVENT WAS THE SAMPLE PROBE PLUGGED WITH GEL FROM A SST TUBE DUE TO SAMPLE PROBE MISALIGNMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THAT AN ERRONEOUSLY LOW CALCIUM RESULT OF 7.9 MG/DL WAS GENERATED BY (B)(4) CHEMISTRY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED A HIGHER RESULT OF 9.2 MG/DL. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU681-02E CLINICAL CHEMISTRY ANALYZER AU681 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU681-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1