BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2902458 · Received January 8, 2013

    Report

    Report Number
    9612296-2013-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD CALLED BACK ON (B)(6) 2012, REPORTING THAT THE LOW SODIUM (NA) RECOVERY FROM THEIR BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER IS STILL ONGOING. THE CUSTOMER HAD INITIALLY REPORTED THE LOW NA RECOVERY ISSUE ON (B)(6) 2012 AND HAD INITIALLY CONFIRMED THAT THE ISSUE WAS RESOLVED POST TROUBLESHOOTING AND PARTS REPLACEMENT. PLEASE SEE MEDWATCH #9612296-2013-00001, FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2012. THE CUSTOMER NOTED THAT THEY NOTICED LOW NA RECOVERY AGAIN ON (B)(6) 2012. THE CUSTOMER INDICATED THAT THE SAMPLES WERE REPEATED AND THE INITIAL LOW NA RECOVERY WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO INJURY OR CHANGE PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. INSTRUMENT PRINTOUTS AND VERBAL EXAMPLES OF PATIENT RESULTS WITH LOW SODIUM ISSUE WERE NOT PROVIDED BY THE CUSTOMER. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED SODIUM (NA) AS WELL AS CHLORIDE (CL) ELECTRODES. THE INSTRUMENT WAS THEN VERIFIED AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE WAS DETERMINED TO BE THE SODIUM AND CHLORIDE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9627 BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMA K.K. AU681-02E

    Patients

    Seq Age Sex Outcome Treatment
    1