BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1963083 · Received January 18, 2011

    Report

    Report Number
    2122870-2011-00064
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LITHIUM HEPARIN PLASMA COLLECTED IN PST TUBES. SAMPLE APPEARANCE WAS SLIGHTLY LIPEMIC. QC PERFORMED ON (B)(6) 2010 WAS WITHIN THE ESTABLISHED RANGES. A SYSTEM CHECK PERFORMED ON (B)(6) 2010 MET THE SPECIFICATIONS. THE CUSTOMER STATED PRECISION ISSUES WERE NOTED DURING A (B)(4) STUDY ON THIS INSTRUMENT. THE DATES AND THE RESULTS WERE NOT SUPPLIED. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010. THE FSE PERFORMED A DIAGNOSTIC SYSTEM CHECK, AND THE RESULTS MET THE SPECIFICATIONS. THE FSE ADJUSTED THE TRANSDUCER VOLTAGE. THE FSE ALSO PERFORMED A HARDWARE VERIFICATION TEST, AND THE RESULTS MET THE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A TROPONIN (ACCUTNI) RESULT IN THE NORMAL REFERENCE RANGE GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. SUBSEQUENT TESTING PRODUCED RESULTS ABOVE THE AMI CUTOFF. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1