BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1982035 · Received February 8, 2011

    Report

    Report Number
    2122870-2011-00341
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    September 30, 2010
    Report Date
    October 6, 2010
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, QC RESULTS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE (B)(6) 2010 - (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A HIGHER THAN EXPECTED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE ON ONE PATIENT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT ANALYSIS, LOWER RESULTS WERE PRODUCED WITH ACCEPTABLE PRECISION WITHIN THE RISK STRATIFICATION RANGE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER 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 MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1