BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1951811 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00085
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD LOADED FRESH ISE REAGENTS, CALIBRATED AND QC WAS WITHIN LAB-ESTABLISHED RANGES. WHEN THE CUSTOMER NOTICED HIGH NA RESULTS, QC WAS RERUN AND FAILED LAB-ESTABLISHED RANGES. SERVICE WAS ALREADY ON-SITE FOR A DIFFERENT ISSUE, AND FOUND THAT THE ISE REAGENT TUBING WAS PINCHED BY THE REAGENT DOOR, WHICH WAS RESTRICTING THE REAGENT FLOW. THE ISSUE HAD OCCURRED WHEN THE CUSTOMER LOADED THE REAGENT AND CLOSED THE REAGENT DOOR. THE FIELD SERVICE ENGINEER (FSE) RESOLVED THE TUBING ROUTING ISSUE, WHICH WAS THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS OBTAINING FALSE HIGH SODIUM (NA), CHLORIDE (CL), CARBON DIOXIDE (CO2) RESULTS, AND FALSE LOW CALCIUM (CALC) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. ONE POTASSIUM (K) SAMPLE EXCEEDED ASSAY PRECISION BY 1.0 MMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. AFTER HIGH NA RESULTS WERE NOTICED, AND TROUBLESHOOTING WAS PERFORMED, SAMPLES WERE RERUN AND REPORTS WERE AMENDED. A TOTAL OF 31 REPORTS WERE CORRECTED AND 28 REPORTS WERE CORRECTED BEFORE THE FALSE RESULTS REACHED THE PHYSICIAN. TWO EXAMPLES OF THE ERRONEOUS RESULTS AND THE RERUN RESULTS, PROVIDED BY THE CUSTOMER. 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® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1