BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172517 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02003
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 4, 2009
    Report Date
    February 5, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BCI OFFERED TO SVC THE INSTRUMENT BUT THE CUSTOMER DECLINED THE OFFER. A FIELD SVC ENGINEER (FSE) DID NOT EVALUATE THE INSTRUMENT. THE SYS CHECKS THAT WERE PERFORMED ON (B)(6) 2009 AND (B)(6) 2009 INDICATE THAT THE INSTRUMENT WAS WITHIN SPECS PRIOR TO THE EVENT. NO DEFINITIVE CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS A SINGLE EVENT INVOLVING SIX PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE AN ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYS FOR 6 PTS. THE PT SAMPLES WERE RETESTED IN AN ALTERNATE LAB WITH A DIFFERENT REAGENT LOT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LAB. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI