BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2955788 · Received February 11, 2013

    Report

    Report Number
    9612296-2013-00019
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K003721
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE BECKMAN COULTER AU2700 CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUSLY LOW SODIUM (NA) RESULTS WITHOUT FLAGS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. REPEAT TESTING ON AN ALTERNATE ANALYZER PRODUCED SODIUM RESULTS HIGHER THAT THE INITIALLY REPORTED RESULTS. THERE WAS NO REPORT OF DEATH OR INJURY, BUT THE IMPACT TO PATIENT TREATMENT IS UNKNOWN. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) CHECKED VARIOUS PARTS AND PERFORMED MAINTENANCE INCLUDING CLEANING DILUTION POT AND ISE DISPENSER HEAD. THE FSE REPLACED CHLORIDE ELECTRODE PER THE CUSTOMER'S REQUEST. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE BY RUNNING ISE CALIBRATION AND QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58565 BECKMAN COULTER AU2700 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU2701-03 ISE UG230V NA

    Patients

    Seq Age Sex Outcome Treatment
    1