BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1833703 · Received September 14, 2010

    Report

    Report Number
    2122870-2010-00524
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 13, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE LI HEPARIN PLASMA AND WERE CENTRIFUGED FOR 3 MINUTES AT 8500 RPM. BOTH SAMPLES WERE ICTERIC. QC PERFORMED PRIOR TO AND AFTER THE EVENT WAS WITHIN THE ESTABLISHED RANGES. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND MET SPECIFICATIONS. THE LABORATORY ANALYZED ACCUTNI IN DUPLICATES AFTER THE EVENT AND ALL RESULTS HAVE BEEN REPRODUCIBLE. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010. FSE REPLACED SOME PARTS, AND PERFORMED PREVENTIVE MAINTENANCE (PM) AND VERIFICATION PROTOCOL. THE RESULTS MET THE SPECIFICATIONS. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE FOR THE EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT IN THE RISK STRATIFICATION RANGE GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING ON THE SAME AND THE SECOND SAMPLE FROM THE PATIENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1