BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1953324 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00077
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAME WAS FRESH AND CENTRIFUGED AT 4200 RPM FOR 6 MINUTES. QC WAS IN CONTROL BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CHECKED THE CRE MODULE AND RECALIBRATED, WHICH MATCHED VALUES FROM THE DAY BEFORE. THE FSE ALSO RAN QC AND A PRECISION TEST, WHICH BOTH MET SPECIFICATIONS. THE ROOT CAUSE WAS NOT DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ONE ERRONEOUSLY HIGH CREATININE (CRE) PATIENT RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER REPEATED THE RESULT ON ANOTHER INSTRUMENT AND PROVIDED NORMAL RESULTS. THE PHYSICIAN QUESTIONED THE RESULTS SO THERE WAS NO CHANGE TO PATIENT TREATMENT.

    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