BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2180528 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02545
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER DECLINED SERVICE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-02544, 2122870-2011-02545.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS, ELEVATED FT3 RESULTS ABOVE THE NORMAL REFERENCE RANGE WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENT SAMPLES. THIS REPORT IS TWO OF TWO AND REPRESENTS THE ERRONEOUS, ELEVATED FT3 RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT SAMPLE ON (B)(6) 2011. SUBSEQUENT TESTING ON THE SAME INSTRUMENT PRODUCED LOWER RESULTS WHICH WERE CONSIDERED VALID. THE INITIAL ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY, AND WHILE THERE HAS BEEN NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. INSTRUMENT QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THIS EVENT. THE INSTRUMENT SYSTEM CHECK AND TWENTY FIVE REPLICATE WET/DRY ULTRASONIC TEST PERFORMED BEFORE THE EVENT BOTH GENERATED ACCEPTABLE RESULTS WITHIN INSTRUMENT SPECIFICATIONS. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    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 ACCESS FREE T3 REAGENT