BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1970799 · Received January 25, 2011

    Report

    Report Number
    2122870-2011-00127
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA WITH A GEL BARRIER. THE CUSTOMER STATED THERE WAS NO VISIBLE FIBRIN IN THE SAMPLE. QC IS PERFORMED DAILY AND WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND THE RESULTS WERE WITHIN THE SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010 AND PERFORMED A HARDWARE VERIFICATION PROTOCOL. THE FSE PERFORMED A CARRYOVER TEST AND A HIGH SENSITIVITY SYSTEM CHECK. ALL 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, ELEVATED ABOVE THE AMI CUTOFF, GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS IN THE RISK STRATIFICATION RANGE. 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 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1