BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2202388 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02664
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    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 ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE CUSTOMER'S INSTRUMENT POSSESSED A CASE TEMPERATURE DIFFERENCE OF FOUR DEGREE CELSIUS WHEN COMPARED AGAINST THE CUSTOMER'S OTHER INSTRUMENT. THE FSE ALSO DETERMINED THAT THE ROOM TEMPERATURE DIFFERENCE AT THE LOCATION OF THE INSTRUMENT, WHEN COMPARED TO THE ROOM TEMPERATURE AT THE LOCATION OF THE CUSTOMER'S OTHER INSTRUMENT, WAS GREATER THAN TWO DEGREES CELSIUS AND COULD ALSO BE CONTRIBUTING, IF NOT CAUSING, THE OBSERVED IMPRECISION. THE FSE DID NOT MAKE ANY REPAIRS TO THE INSTRUMENT AT THE TIME OF SERVICE. ALTHOUGH INSTRUMENT TEMPERATURE AFFECTS WERE DISCUSSED WITH THE CUSTOMER IN DETAIL BY THE FSE AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT ARE: 2122870-2011-02660; 2122870-2011-02661; 2122870-2011-02662; 2122870-2011-02663; 2122870-2011-02664; 2122870-2011-02665.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE CARDIAC TROPONIN (ACCUTNI) AND CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE PATIENTS OVER MULTIPLE DAYS. INITIAL RESULTS GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM VARIED UPON REPEAT ON THE SAME INSTRUMENT. THIS IS REPORT FOUR OF SIX AND REPRESENTS THE IMPRECISE CARDIAC TROPONIN (ACCUTNI) RESULTS GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS ON (B)(6) 2011. THE IMPRECISE ACCUTNI RESULTS ASSOCIATED WITH THIS EVENT WERE RELEASED FROM THE LABORATORY HOWEVER THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ACCUTNI QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT AND SYSTEM CHECK RESULTS GENERATED PRIOR TO THE EVENT MET SPECIFICATIONS. AN ACCUTNI PRECISION ASSESSMENT OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DEMONSTRATED THAT ACCUTNI PRECISION WAS ACCEPTABLE. 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT