BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2474904 · Received March 1, 2012

    Report

    Report Number
    2050012-2012-00597
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGZ
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE TESTED IN 16X100 OPEN TUBES. QC WAS WITHIN LAB-ESTABLISHED RANGES PRIOR TO THE EVENT , BUT WAS LOW AFTER THE EVENT. SERVICE WAS DISPATCHED FOR THIS EVENT. THE FSE FOUND BLUE-GREY BUILD UP AROUND THE CO2 ELECTRODES AND A WHITE BUILDUP IN THE CL PORT. THERE WAS SOME BUILD UP IN THE LINE FROM THE INJECTION PORT TO THE WASTE SOLENOID VALVE. EIC (ELECTROLYTE INJECTION CUP) WAS CLEANED OUT. THE FSE REPLACED SODIUM (NA) REFERENCE ELECTRODE, NA MEASURE ELECTRODE, AND THE CARBON BRIDGE. CONTROLS WERE RUN AND ALL RESULTS WERE ON THE ESTABLISHED MEANS. THE INSTRUMENT PERFORMANCE WAS VERIFIED. AS OF (B)(4) 2012, THE CUSTOMER HAD NOT SEEN ANY CL ISSUES IN THE LAST TWO FULL NIGHTS OF OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT CHLORIDE (CL) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM HAD BEEN DRIFTING LOW AFTER APPROXIMATELY 200 - 300 SAMPLES WERE RUN. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT RECALIBRATING THE ASSAY BROUGHT THE QC AND PATIENT RESULTS BACK INTO THE EXPECTED RANGES. THE CUSTOMER VERBALLY PROVIDED A FEW EXAMPLES, OF WHICH THE LARGEST DIFFERENCE WAS 10 MMOL/L BETWEEN THE INITIAL AND REPEAT RESULTS. THE INITIAL AND THE REPEAT RESULTS AFTER RECALIBRATION WERE 92 AND 102 MMOL/L, RESPECTIVELY, AND THIS DIFFERENCE EXCEEDS ASSAY PRECISION CLAIMS. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CGZ BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1