BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2162864 · Received July 15, 2011

    Report

    Report Number
    2122870-2011-02247
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. QC RESULTS PERFORMED WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. ON (B)(6) 2011, SYSTEM CHECK WAS PERFORMED AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) VERIFIED INSTRUMENT HARDWARE PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. FSE WAS UNABLE TO DETECT ANY ISSUES WITH THE INSTRUMENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. THIS MDR IS ASSOCIATED WITH MDRS: 2122870-2011-02227, 2122870-2011-02246.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNI RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. PATIENT RESULTS ARE PROVIDED. AFFECT TO PATIENT OR TREATMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1