BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1853402 · Received October 5, 2010

    Report

    Report Number
    2050012-2010-00928
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 4, 2010
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN IN A B-D LITHIUM HEPARIN GEL SEPARATOR PLASMA PLASTIC TUBE AND CENTRIFUGED AT 3600 RPM AT ROOM TEMPERATURE IN A SWINGING BUCKET CENTRIFUGE. CRP WAS CALIBRATED AND QC RESULTS, PRIOR TO AND AFTER THE EVENT, WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER CONTACTED THE BCI HOTLINE BECAUSE THERE WAS A SHIFT IN QC RESULTS WHEN CRP REAGENT WAS PUT INTO USE. THE SHIFTS ON 2 QC SAMPLES WERE WITHIN THE LAB'S ESTABLISHED QC RANGES. A CONTROL SAMPLE WAS SENT TO THE CUSTOMER FOR TROUBLESHOOTING. THE CONTROL RECOVERED WITHIN RANGE. SERVICE WAS NOT REQUESTED FOR THIS EVENT. THE ERROR WAS NOT REPRODUCIBLE AND LIMITED TO ONE PATIENT SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY HIGH C-REACTIVE PROTEIN (CRP) RESULT THAT WAS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER ON ONE PATIENT SAMPLE. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED A LOWER RESULT. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY, BUT WAS AMENDED BY THE SUBSEQUENT RESULT. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR