BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2160964 · Received July 13, 2011

    Report

    Report Number
    2122870-2011-02285
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE INFORMATION FOR SAMPLE COLLECTION AND CENTRIFUGATION. THE LABORATORY DOES NOT HAVE A REPEAT PROTOCOL, BUT DOES HAVE AN ACCUTNI DELTA CHECK SYSTEM IN PLACE. PER THE CUSTOMER, THE INSTRUMENT WAS PERFORMING WITHIN QC SPECIFICATIONS. NO SPECIFIC EVENT QC DATA WAS SUPPLIED. THE CUSTOMER INDICATED THAT THE LABORATORY'S INVESTIGATION DETERMINED THAT PRE-ANALYTICAL SAMPLE ISSUES (FIBRIN CLOT PRESENCE IN SAMPLE) CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER, INC. (BEC) PER MARKETING SURVEY PROGRAM (MSP) PROCEDURES, A CUSTOMER REPORTED THAT THEIR LABORATORY OBTAINED NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULT FOR ONE (1) PATIENT, GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER. THE PATIENT'S FIRST DRAW SAMPLE RECOVERED WITHIN THE NORMAL REFERENCE RANGE FOR ACCUTNI. A SECOND DRAW A FEW HOURS LATER RECOVERED HIGHER ACCUTNI RESULT THAN THE UPPER LINEARITY SPECIFICATION LIMITS FOR THE ASSAY. THE PHYSICIAN WAS VERBALLY COMMUNICATED ABOUT THE ISSUE OBSERVED WITH THE SECOND DRAW SAMPLE. A THIRD SAMPLE WAS DRAWN FOR TESTING, WHICH RECOVERED WITHIN THE NORMAL REFERENCE RANGE FOR ACCUTNI CONFIRMING INITIAL VALUE OF THE FIRST SAMPLE DRAW. THE CUSTOMER INDICATED THAT A FIBRIN CLOT WAS LATER DETECTED IN THE SECOND DRAW SAMPLE. THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI OR AN INSTRUMENT MALFUNCTION. THE CUSTOMER WAS ASKED TO PROVIDE SPECIFIC DATA TO INCLUDE PATIENT'S DEMOGRAPHICS, SAMPLE DATA REPORT, DATE OF EVENT; HOWEVER, THE CUSTOMER DECLINED TO PROVIDE THIS INFORMATION. THE CUSTOMER DID NOT REPORT ANY AFFECT TO THE PATIENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1