BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3842233 · Received June 1, 2014

    Report

    Report Number
    9612296-2014-00085
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND IDENTIFIED FAULTY ION SELECTIVE ELECTRODE (ISE) BUFFER DILUTION VALVES WHICH WERE CAUSING INSUFFICIENT BUFFER TO BE DISPENSED INTO THE DILUTION POT. THE FSE PROCEEDED TO REPLACE BOTH VALVES TO RESOLVE THE SODIUM (NA) AND POTASSIUM (K) RECOVERY ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH SODIUM (NA) AND POTASSIUM (K) RESULTS FOR FIVE (5) PATIENTS FROM THE BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPEATED THE SAMPLES AND OBTAINED LOWER NA AND K RESULTS. THE CUSTOMER STATED THAT THE INITIAL RESULTS WERE TWO (2) TO THREE (3) TIMES HIGHER THAN THE NORMAL RANGE. THE CUSTOMER REQUESTED FOR SERVICE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320625 BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1