BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2395954 · Received January 3, 2012

    Report

    Report Number
    2050012-2012-00016
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    November 24, 2011
    Report Date
    November 30, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    CKB
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO ERRONEOUS HIGH ETHANOL RESULTS GENERATED ON THE AU400 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE DOCTOR. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. QC OUT HIGH AFTER EVENT. PRIOR TO THE EVENT, THE INSTRUMENT HAD A NEW SAMPLE PROBE, NEW LAMP, WASH PUMP REPLACED, AND CUVETTES CLEANED. POST THE EVENT, THE CUSTOMER USE A NEW LOT OF CALIBRATOR AND FRESH REAGENT, CLEANED WATER TANK, REPLACED "BEADED" WATER TANKS ON WATER SYSTEM, AND CULTURED CLEANED. ON (B)(4) 2011, A FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE AS PROBLEM IS INTERMITTENT. VERIFIED ALL ALIGNMENTS, TEMPERATURES AND WASH USAGE. ALL CONSUMABLES HAVE BEEN REPLACED. THE CUSTOMER IS GOING TO RUN ALL ALCOHOLS ON THE AU640 IN DUPLICATE. ON (B)(4) 2011, FSE DECONTAMINATED THE AU400 AND ALL QC WERE WITHIN SPECIFICATION. WILL MONITOR. ROOT CAUSE FOR THE EVENT APPEARS TO BE THE WATER SYSTEM AND CONTAGION OF THE AU400

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 CLINICAL CHEMISTRY ANALYZER ACID PHOSPHATASE, NAPHTHYL PHOSPHATE CKB BECKMAN COULTER MISHIMA K.K. AU403-02E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1