BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1333350 · Received March 5, 2009

    Report

    Report Number
    2050012-2009-00021
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 5, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RECOVERED WITHIN LAB'S ESTABLISHED RANGES. SERVICE WAS NOT INITIATED FOR THIS EVENT. BECKMAN COULTER INC., (BCI), CONTACTED THE CUSTOMER ON 02/17/09, AND THEY BELIEVE IT IS A SAMPLE/PATIENT SPECIFIC ISSUE. NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS AVAILABLE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A PATIENT SAMPLE WAS TESTED FOR PHENYTOIN (PHY) AND A RESULT OF 21UG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND IT WAS QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-TESTED ON THE NEXT DAY AND REPEATED RESULT WAS 10.7UG/ML. A 2ND SAMPLE COLLECTED FROM THE PATIENT 2 HOURS AFTER ADMINISTRATION OF PHY GAVE A RESULT OF "<2.5UG/ML". THE TRUE RESULT HAS NOT BEEN DETERMINED. IT IS UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1