BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2874476 · Received December 14, 2012

    Report

    Report Number
    2050012-2012-01946
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER HAD BEEN INTERMITTENTLY GENERATING ERRONEOUSLY LOW SODIUM (NA) RESULTS. THE CUSTOMER STATED THAT THE RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT HE RESULTS WERE QUESTIONED AND THERE WAS NO EFFECT TO PATIENT TREATMENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS, BUT REPORTED THAT THE LABORATORY FAILED PROFICIENCY SURVEY FOR SODIUM ASSAY. BEC FIELD SERVICE ENGINEER (FSE) REVIEWED ISE (ION SELECTIVE ELECTRODE) CALIBRATION AND QC LOGS ON SITE AND FOUND THAT ALL RESULTS WERE WITHIN THE EXPECTED RANGES. THE FSE INSPECTED ISE SYSTEM AND DETERMINED THAT THE SAMPLE PROBE SHOULD BE REPLACED. THE FSE PRIMED ISE AFTER REPLACING THE SAMPLE PROBE, AND PERFORMED CALIBRATION AND QC. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS AND NO FURTHER ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. AU481-10E NA

    Patients

    Seq Age Sex Outcome Treatment
    1