BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1982040 · Received February 8, 2011

    Report

    Report Number
    2050012-2011-00402
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE SAMPLES WERE NOT ICTERIC OR HEMOLYZED, BUT WERE SLIGHTLY TURBID. NO SYSTEM ISSUES WERE NOTED. CUSTOMER REPORTS THAT CONTROL RECOVERY HAS BEEN ACCEPTABLE FOR BOTH CHEMISTRIES. PER THE CUSTOMER, THIS EVENT APPEARS TO BE A SAMPLE-SPECIFIC ISSUE, SO SERVICE WAS NOT REQUESTED. CUSTOMER DID NOT PROVIDE A SAMPLE TO SEND TO BCI FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A SPECIFIC PATIENT'S SAMPLE RESULTS WERE DISCREPANT BETWEEN C - REACTIVE PROTEIN (CRP) AND CRP-H THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. CUSTOMER NOTED THAT THE CRP AND CRPH RESULTS WERE RUN AT DIFFERENT LABORATORIES ON DIFFERENT INSTRUMENTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT WAS RETESTED DUE TO THE DISCREPANT RESULTS. IMPACT ON PATIENT TREATMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR