BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3559755 · Received January 7, 2014

    Report

    Report Number
    9612296-2014-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013. THE FSE CLEANED ALL ISE TUBING, PRIMED, AND RECALIBRATED BOTH CELLS. ON (B)(6) 2013, THE CUSTOMER CALLED AGAIN REPORTING ISE RESULTS WERE NOT MATCHING WHEN REPEATED. IN ADDITION, ISE CLOT DETECTION ERRORS WERE BEING GENERATED WITH NO CLOTS BEING LOCATED IN SAMPLE OR SYSTEM. THE FSE RETURNED AND VERIFIED THE PROBLEM WAS OCCURRING ON BOTH ISE CELLS. THE FSE REPLACED A WASH VALVE, THE SAMPLE SYRINGE, THE CELL 1 SAMPLE POT STIRRER MOTOR, AND THE CELL 1 BUFFER SYRINGE. FOLLOWING SEVERAL GOOD CALIBRATIONS AND PRECISION RUNS, ISE GENERATED AN "ISE CLOT DETECT ERROR". THE FSE VERIFIED NO OBSTRUCTIONS WERE PRESENT. THE CLOT SENSOR (MU6197) WAS REPLACED. THE ISE TUBING AND WASH SYRINGE WERE ALSO REPLACED. THE CUSTOMER CALLED HOTLINE AGAIN ON (B)(6) 2013 TO REPORT ERRATIC ISE RESULTS. SERVICE WAS REQUESTED AGAIN. THE FSE REPLACED THE SAMPLE VALVE AND SAMPLE PROBE. THE FSE PERFORMED CALIBRATION AND QC WITH ACCEPTABLE RECOVERY. DIAGNOSTIC SEQUENCE MEASUREMENTS WERE PERFORMED; N=30. NO ISSUES WERE NOTED. THE SYSTEM WAS VALIDATED AS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER ISE ISSUES HAVE BEEN REPORTED. THE SPECIFIC FAILURE MODE COULD NOT BE IDENTIFIED AS MULTIPLE PARTS WERE REPLACED ALONG WITH GENERAL ISE MAINTENANCE BEING PERFORMED. THE MANUFACTURER REFERENCE NUMBERS FOR THIS EVENT ARE (B)(4). MDR REPORT NUMBERS 9612296-2014-00001 AND 9612296-2014-00002 WERE COMPLETED TO ACCOUNT FOR THE OTHER 2 DAYS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO HOTLINE OF NOTICING ERRATIC ISE RESULTS. THE CUSTOMER CITED THE EXAMPLE OF AN INITIAL SODIUM (NA) RESULT OF 170 MMOL/L THAT WAS 130 MMOL/L WHEN REPEATED. THE CUSTOMER STATED THAT BOTH ISE CELLS WERE SHOWING ERRATIC RESULTS: BOTH HIGH AND LOW FLIERS HAD BEEN NOTED. THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER INFORMATION OR DOCUMENTATION. THE CUSTOMER DID CONFIRM THAT NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO AFFECT TO PATIENTS. THE CUSTOMER STATED THAT THEY CLEANED, PRIMED AND RECALIBRATED THE INSTRUMENT, BUT CONTINUED TO SEE ERRATIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9801 AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU5431 NA

    Patients

    Seq Age Sex Outcome Treatment
    1