BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON CX5CE

    MDR report key: 546079 · Received April 6, 2004

    Report

    Report Number
    2050012-2004-00007
    Event Type
    Other
    Date Received
    April 6, 2004
    Date of Event
    March 9, 2004
    Report Date
    April 6, 2004
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, A SYNCHRON CX5CE INSTRUMENT GENERATED ELEVATED PHENYTOIN (PHY) RESULTS. THE EVENT OCCURRED ON TWO DIFFERENT SAMPLES (A&B) FROM ONE PT. THE PHY RESULT FOR SAMPLE A WAS 34.5 UG/ML. THE ELEVATED RESULT WAS REPORTED OUT OF THE LAB AND THE PHYSICIAN QUESTIONED THE RESULTS. SAMPLE A WAS SENT TO A REFERENCE LAB FOR ADDITIONAL PHY TESTING. SAMPLE A WAS RETESTED AT THE REFERENCE LAB AND THE RESULT WAS 13.5 UG/ML. TESTING METHODOLOGY USED BY THE REFERENCE LAB WAS FLUORESCENT EIA. THE FOLLOWING DAY, NEW SAMPLE (B) WAS COLLECTED FROM THE PT AND TESTED FOR PHY ON THE CX5CE. THE PHY RESULT FOR SAMPLE B WAS 35.4 UG/ML. SAMPLE B WAS SENT TO A DIFFERENT REFERENCE LAB THAT USES THE FLUORESCENT EIA METHODOLOGY FOR ADDITIONAL PHY TESTING. SAMPLE B WAS RETESTED AT THE REFERENCE LAB AND RESULT WAS 17 UG/ML. IT IS UNKNOWN IF THERE HAS BEEN ANY CHANGE IN PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5CE CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. CX5CE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other