BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2011134 · Received March 8, 2011

    Report

    Report Number
    2122870-2011-00626
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT NONE OF THE SAMPLES APPEARED TO HAVE ANY FIBRIN OR APPEARED TO BE "ABNORMAL." THERE WERE NO RESULT FLAGS GENERATED WITH THESE RESULTS. QC RUN PRIOR TO AND AFTER THE EVENT, WAS RECOVERING WITHIN RANGE. SYSTEM CHECKS RUN ON (B)(4) 2011 AND (B)(4) 2011 PASSED ALL SPECIFICATIONS. CUSTOMER DID NOT REPORT ANY EVENT LOG MESSAGES ASSOCIATED WITH THIS EVENT. CUSTOMER UTILIZES THEIR STAFF BIO-MED ENGINEER TO MAINTAIN AND REPAIR THIS INSTRUMENT. PER THE ENGINEER, EVERYTHING "APPEARED TO BE RUNNING WITHIN SPECIFICATIONS". REAGENT CAROUSEL WAS DIRTY, WHICH WAS CLEANED. THE INSTRUMENT WAS VERIFIED AS PERFORMING TO BCI PERFORMANCE SPECIFICATIONS. NO CLEAR ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ELEVATED TROPONIN (ACCUTNI) RESULTS, IN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS. REPEAT TESTING ON AN ALTERNATE METHOD RESULTED AS "NEGATIVE" AND THESE RESULTS WERE REPORTED OUT OF THE LAB. THE ELEVATED RESULTS GENERATED BY THE ACCESS 2 ANALYZER WERE NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1