BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172093 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01782
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    January 29, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER DID NOT EVALUATE THE DEVICE. THE ACCUTNI QUALITY CONTROL (QC) DATA WAS REVIEWED AND IT WAS WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT. THE SYSTEM CHECK DATA THAT WAS PERFORMED ON (B)(6) 2008 WAS REVIEWED AND IT WAS WITHIN INSTRUMENT SPECIFICATIONS. FOLLOWING THIS EVENT, BCI SENT A NEW REAGENT LOT TO THE CUSTOMER TO REPLACE THE REAGENT LOT AT THE USER SITE. THE CUSTOMER PERFORMED RERUNS OF THE PT SAMPLES AND RESULTS WERE WITHIN EXPECTED REFERENCE RANGE. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT. THIS IS TWO OF THREE SEPARATE MDR REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-01781, 01783 FOR ALL EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2009 IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PTS. THE INITIAL ERRONEOUSLY ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LAB. THE CUSTOMER HAS INDICATED THAT FROM (B)(6), THEY HAVE SEEN AN INCREASE IN PT RESULTS IN THE INDETERMINATE RANGE. ONCE THE CUSTOMER RECEIVED ANOTHER LOT THEY SAW A DECREASE IN PT RESULTS IN THE INDETERMINATE RANGE. IT IS UNK IF THIS IS RELATED TO REAGENTS. THE PT SAMPLES WERE RETESTED ON ANOTHER INSTRUMENT AND THE RESULTS RECOVERED WITHIN THE NORMAL REFERENCE RANGE. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    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 72 YR ACCESS ACCUTNI