BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2111009 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01653
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) INSPECTED ALL HARDWARE ON THE INSTRUMENT. NO INSTRUMENT ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) A LOWER THAN EXPECTED FREE TOTAL THYROXINE (FRT4) RESULT BELOW THE NORMAL REFERENCE RANGE WAS GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE RESULTS WAS REPORTED OUT OF THE LABORATORY, HOWEVER THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING OF THE PATIENT SAMPLE ON (B)(6) 2011 ON THE SAME INSTRUMENT PRODUCED A HIGHER RESULT WITHIN THE NORMAL REFERENCE RANGE THAT BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION AND WAS CONSIDERED VALID. QUALITY CONTROL (QC) RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES AT THE TIME OF THE EVENT AND THE SYSTEM CHECK PERFORMED PRIOR TO THE EVENT YIELDED ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR ACCESS FREE T4