BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2160985 · Received July 13, 2011

    Report

    Report Number
    2050012-2011-03070
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MODULAR CHEMISTRY CRANE. ALTHOUGH REPAIRS WERE MADE TO THE INSTRUMENT PRIOR TO RETURNING IT INTO SERVICE, HOWEVER A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2010 THEY OBTAINED ERRONEOUS GLUCOSE (GLU) RESULTS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR TWO PATIENT SAMPLES. THE ERRONEOUS GLU RESULTS WERE NOT RELEASED FROM THE LABORATORY, AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT QUALITY CONTROL (QC) RESULTS FAILED TO MEET CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THE EVENT. INSTRUMENT QUALITY CONTROL RESULTS WERE ACCEPTABLE AFTER INSTRUMENT CUP MAINTENANCE WAS REPEATED BY DIFFERENT LABORATORY STAFF UTILIZING A NEW REAGENT CONTROL. REPEAT GLU RESULTS WERE DIFFERENT FROM INITIAL RESULTS. IT IS UNKNOWN WHICH RESULTS WERE REGARDED AS CORRECT AND VALID. THE CUSTOMER DID NOT REPORT ANY OTHER CHEMISTRY ISSUES. PATIENT INFORMATION AS WELL AS SAMPLE PREPARATION AND HANDLING INFORMATION ASSOCIATED WITH THIS EVENT WERE NOT SUPPLIED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1