BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2425649 · Received January 23, 2012

    Report

    Report Number
    2050012-2012-00163
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    December 30, 2011
    Report Date
    December 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGJ
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. EVALUATED THE INSTRUMENT BY LEADING THE CUSTOMER THOUGH ROUTINE TROUBLESHOOTING ACTIVITIES. CUSTOMER TECHNICAL SERVICES RECOMMENDED THAT THE CUSTOMER FLUSH THE CHEMISTRY CARTRIDGE (CC) SAMPLE PROBE, AND THEN RECALIBRATE AND PERFORM A PRECISION RUN ON CHEMISTRY QUALITY CONTROL (QC) RESULTS. FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THE CUSTOMER HAD CLEANED THE CC PROBE AND HAD EXECUTED A TEN REPETITION QC PRECISION ASSESSMENT WITH ACCEPTABLE RESULTS. THE MG CARTRIDGE WAS NO AVAILABLE FOR BECKMAN COULTER INC. ASSESSMENT. ROOT CAUSE IS NOT KNOWN BUT BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING APPEARS TO HAVE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, ELEVATED MAGNESIUM (MG) RESULTS WERE GENERATED ON A UNICEL DXC 800 SYNCHRON SYSTEM FOR THREE PATIENT SAMPLES. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THAT INITIAL AND CRITICAL RERUN RESULTS WERE ELEVATED WHEN COMPARED TO REPEAT RESULTS SUBSEQUENTLY GENERATED. THE REPEAT RESULTS WERE ASSOCIATED WITH THE USE OF A NEW REAGENT PACK ACCORDING TO THE CUSTOMER. OTHER CHEMISTRIES WERE RUN FOR THESE SAMPLES BUT WERE NOT REPEATED. NO ERRONEOUS MG RESULTS WERE RELEASED FROM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE INSTRUMENT MG QUALITY CONTROL (QC) RESULTS DURING THE TIME FRAME OF THE EVENT RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS. NO SAMPLE ISSUES WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNCHRON MAGNESIUM REAGENT