BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1600067 · Received February 16, 2010

    Report

    Report Number
    2122870-2010-00057
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KXT
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALIBRATION, QC AND SYSTEM CHECK DATA WERE WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED HARDWARE VERIFICATION AND CARRYOVER TESTING; RESULTS MET PUBLISHED SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A DIGOXIN RESULT ABOVE THE THERAPEUTIC RANGE FOR ONE PATIENT SAMPLE. THE RESULT OF 2.11 NG/ML WAS REPORTED OUT OF THE LAB AND IT WAS QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-TESTED SEVERAL TIMES AND REPEATED RESULTS WERE BELOW THE THERAPEUTIC RANGE OF 0.35-0.70 NG/ML. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER KXT BECKMAN COULTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1