BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1296218 · Received December 8, 2008

    Report

    Report Number
    2122870-2008-00401
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Date of Event
    November 19, 2008
    Report Date
    December 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE DRAWN IN THE ER, INTO 13X75 BD LITHIUM HEPARIN TUBES. THE SPECIMENS WERE CENTRIFUGED AT 2,500 RPM FOR 10 MINUTES. THREE LEVELS OF QC IS RUN EVERY 24 HOURS AND RESULTED WITHIN RANGE DURING THE TIME OF THE EVENT. A SYSTEM CHECK PERFORMED ON 11/15/2008 MET SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND NOTED VACUUM OVER PRESSURE LIMIT ERRORS. THE VACUUM VALVE WAS STUCK SHUT AND WAS REPLACED. THE FSE PERFORMED ASPIRATE AND DISPENSE VOLUME CHECKS, VERIFIED ALIGNMENTS, AND PERFORMED A SYSTEM CHECK, WHICH MET SPECIFICATIONS. THE FSE PERFORMED A DIAGNOSTIC TEST, WHICH FAILED. THE FSE RETURNED TO THE CUSTOMER SITE AND PERFORMED ADDITIONAL TROUBLESHOOTING AND REPAIRS TO THE INSTRUMENT. THE FSE RAN SYSTEM CHECK AND PRECISION TESTING USING ALL LEVELS OF ACCU TNI QC, WHICH BOTH MET SPECIFICATIONS. BCI CONTACTED THE CUSTOMER SITE ON 12/01/2008, TO F/U THE EVENT. THE CUSTOMER HAD NO FURTHER ISSUES TO REPORT SINCE SERVICE WAS ON SITE. HARDWARE ISSUES ADDRESSED BY FSE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PTS. PT A AND B SAMPLES WERE TESTED FOR ACCU TNI AND RESULTS OF 0.63NG/ML AND 0.85NG/ML WERE OBTAINED RESPECTIVELY. THE ORIGINAL SAMPLES OF BOTH PTS WERE RE-TESTED AND REPEATED RESULTS WERE: 0.02NG/ML FOR PT A, AND 0.01NG/ML FOR PT B. THE SAMPLES WERE TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND RESULTS MATCHED THE REPEAT RESULTS. THE RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNK IF PT TREATMENT WAS AFFECTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 2

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PTS. PT A AND B SAMPLES WERE TESTED FOR ACCU TNI AND RESULTS OF 0.63NG/ML AND 0.85NG/ML WERE OBTAINED RESPECTIVELY. THE ORIGINAL SAMPLES OF BOTH PTS WERE RE-TESTED AND REPEATED RESULTS WERE: 0.02NG/ML FOR PT A, AND 0.01NG/ML FOR PT B. THE SAMPLES WERE TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND RESULTS MATCHED THE REPEAT RESULTS. THE RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNK IF PT TREATMENT WAS AFFECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2 NA