BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2052696 · Received April 13, 2011

    Report

    Report Number
    2050012-2011-01090
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD PREVIOUSLY REPLACED THE CO2 MEMBRANE. THE CUSTOMER NOTED THAT IN THE DAYS PRIOR TO THE EVENT, THEY HAD TO RECALIBRATE CO2 MORE OFTEN. WHEN THE TREND WAS NOTICED, QC WAS RERUN AND WAS LOW. SERVICE REPLACED BOTH CO2 ELECTRODES AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW CARBON DIOXIDE (CO2) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE TREND WAS NOTICED, ELEVEN (11) SAMPLES WERE RERUN ON THE CUSTOMER'S OTHER INSTRUMENT AND 2 REPORTS WERE AMENDED. OF THE ELEVEN (11) SAMPLES, THE DIFFERENCE IN RESULTS FOR SEVEN (7) OF THE SAMPLES EXCEEDED ASSAY PRECISION CLAIMS. IT IS UNKNOWN WHICH TWO (2) SAMPLES WERE AMENDED. THE SEVEN (7) SAMPLES THAT EXCEEDED CLAIMS ARE SHOWN. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1