BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1061498 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00188
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 17, 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
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED INTO 13 X 100 PLASTIC SERUM TUBES WITH GEL SEPARATOR AND WERE CENTRIFUGED AT 1,500 RPM FOR 7 MINUTES. BD RECOMMENDS A 10 MINUTE SPIN TIME FOR THE TUBE TYPE IN USE. PER CUSTOMER, SYSTEM CHECKS AND QC HAVE BEEN PASSING. BASED ON PRINT SCREEN OF THE EVENT LOG, WARNING ERRORS WERE POSTED IN 2008. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED SEVERAL HARDWARE ISSUES WHICH HE CORRECTED: THE FSE REPLACED A VACUUM PUMP, REALIGNED A PIPETTOR, READJUSTED ULTRASONIC VOLTAGE, AND CLEANED A WASH TOWER. THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH PASSED. THE CUSTOMER STATED TO THE FSE THEY DISCOVERED SAMPLES FROM THE PATIENT IN QUESTION WERE OBSERVED TO HAVE MICRO-CLOTS FOLLOWING INITIAL TESTING. A LATER TIME THE CUSTOMER PROVIDED THAT THE PATIENT'S BLOOD IS TAKING TOO LONG TO FORM A CLOT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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 ELEVATED TROPONIN (ACCU TNI) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR A SINGLE PATIENT SAMPLES. AN INITIAL ACCU TNI RESULT WAS 6.17NG/ML. THE SAMPLE WAS RE-TESTED AND 2 RESULTS OF 0.03NG/ML WERE OBTAINED. TWO MORE SAMPLES FROM THIS PATIENT GAVE RESULTS 0.03NG/ML INITIALLY AND UPON REPEAT. A RESULT FROM 4TH SAMPLE WAS 7.57NG/ML INITIALLY AND 0.05NG/ML AND 0.04NG/ML UPON REPEAT. THE ERRONEOUS VALUES WERE REPORTED OUT OF THE LAB. THERE HAS BEEN NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT REPORTED TO BCI TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA