BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU481-10E CLINICAL CHEMISTRY ANALYZER (WITH ISE)

    MDR report key: 3188978 · Received June 25, 2013

    Report

    Report Number
    9612296-2013-00078
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT AVAILABLE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE REVIEWED QC DATA AND OBSERVED THE NA RESULTS DRIFTING LOW. THE FSE INDICATED THAT NA CALIBRATION SLOPES WERE PASSING. REVIEW OF THE PRECISION RUN DATA PROVIDED BY THE CUSTOMER SHOWS A SLIGHT ELEVATION IN THE COEFFICIENT VARIATIONS (CVS) RECOVERED FOR THE NA ANALYTE. THE FSE CLEANED THE IONIZED SELECTIVE ELECTRODE (ISE) SYSTEM AND REPLACED THE NA ELECTRODE WHICH RESOLVED THE ISSUE. FAILURE MODE: NA ELECTRODE FAILURE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING INTERMITTENT ISSUES WITH SODIUM RESULTS (QUALITY CONTROL AND PATIENT RESULTS) SINCE (B)(6) 2013 GENERATED ON THE (B)(4) CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THE ISSUE WOULD BE CORRECTED BY CLEANING AND RECALIBRATING THE SYSTEM; HOWEVER, THE ISSUE WOULD RETURN OVER TIME. THE CUSTOMER ALSO STATED THAT THEY ARE ALSO NOW EXPERIENCING CHLORIDE (CL) ISSUES. THE CUSTOMER REPORTED THAT APPROXIMATELY TWENTY (20) CORRECTED PATIENT RESULTS WERE ISSUED FOR THIS EVENT. THE CUSTOMER IS UNABLE TO PROVIDE ACTUAL PATIENT DATA. THE CUSTOMER INDICATED THAT WHEN THE PATIENT RESULTS ARE LOW THE CUSTOMER WOULD RECALIBRATE AND RERUN. THE RERUN WOULD YIELD HIGHER RESULTS THAT WERE CONSIDERED CORRECT. THE CUSTOMER ALSO NOTED THAT THIS OCCURS WHEN RUNNING QUALITY CONTROLS (QC). THE CUSTOMER INDICATED THAT QC RECOVERED VALUES OF 130/131 MMOL/L ON (B)(6) 2013. THE CUSTOMER RECALIBRATED AND RERAN THE SAME CONTROLS SHORTLY AFTER AND RECOVERED VALUES OF 142/143 MMOL/L. THE CUSTOMER HAS NOT BEEN NOTIFIED OF ANY SPECIFIC AFFECT TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287336 OLYMPUS AU481-10E CLINICAL CHEMISTRY ANALYZER (WITH ISE) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU481-10E (WITH ISE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1