BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2001231 · Received February 24, 2011

    Report

    Report Number
    2122870-2011-00484
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE LITHIUM HEPARIN PLASMA THAT WERE CENTRIFUGED FOR 10 MINUTES AT 3,500 RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 AND MET SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG. PER CUSTOMER, THERE WERE NO ISSUES WITH ANY OTHER ASSAYS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SUBSTRATE AND ASPIRATE PROBES. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF AND WITHIN THE RISK STRATIFICATION RANGE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS. SUBSEQUENT TESTING ON AN ALTERNATE ANALYZER PRODUCED RESULTS IN THE NORMAL REFERENCE RANGE. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1