BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2440199 · Received February 6, 2012

    Report

    Report Number
    2050012-2012-00300
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE CUSTOMER HAS PREVIOUSLY REPLACED THE SAMPLE POT AND ION-SELECTIVE ELECTRODE (ISE) TUBING. THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT THE INSTRUMENT HAD NOT BEEN PRIMED ENOUGH TO ALLOW FOR RELIABILITY AND STABILITY, THUS CAUSING THE DRIFT IN THE RESULTS. FSE HAD THE CUSTOMER RECALIBRATE AND RERUN THEIR QC TO VALIDATE THEIR REAGENT. SYSTEM CAME UP OPERATIONAL. THE FSE VERIFIED ISE ALIGNMENTS. THE FSE INSPECTED THE SAMPLE PROBE AND SYRINGES WITH NO ADDITIONAL PROBLEMS FOUND. THE INSTRUMENT WAS RETURNED INTO OPERATION AFTER COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS. THE ROOT CAUSE OF THIS EVENT WAS FAULTY ISE SAMPLE POT/TUBING AND LACK OF APPROPRIATE INSTRUMENT PRIMING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(4) 2012, ERRONEOUS LOW ION-SELECTIVE ELECTRODE (SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL)) RESULTS WERE GENERATED FROM AN OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER FOR THIRTY TWO PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. REPEAT RESULTS WERE HIGHER. THE ORIGINAL SAMPLES WERE SERUM AND THE REPEAT TESTING WAS PERFORMED FROM THE ORIGINAL TUBE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ANALYTE PERFORMANCE DATA INDICATED THAT QUALITY CONTROL RESULTS MET CUSTOMER ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT, HOWEVER AFTER THE EVENT, THE QC RESULTS WERE TRACKING LOW. UPON RECALIBRATION OF THE ANALYTE/INSTRUMENT QC RESULTS WERE BACK AT TARGET VALUES. THE CUSTOMER REPORTED THAT MAINTENANCE ON THE INSTRUMENT WAS CURRENT. THE CUSTOMER PROVIDED ADDITIONAL PATIENT DATA HOWEVER THE RESULTS WERE NOT PERTINENT TO THIS EVENT AND HENCE WERE NOT INCLUDED IN THIS REPORT. NO PATIENT SPECIFIC INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY JGS BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1