BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2105946 · Received May 27, 2011

    Report

    Report Number
    2122870-2011-01602
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLASSIFICATION PRODUCT CODE OF THE SUSPECT MEDICAL DEVICE INVOLVED WAS INCORRECTLY IDENTIFIED AS CGN IN THE ORIGINAL 3500A. THE CORRECT CLASSIFICATION PRODUCT CODE IS JJE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED SERVICE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THIS REPORT IS ASSOCIATED WITH THE FOLLOWING MDRS: 2122870-2011-01544, 2122870-2011-01596, 2122870-2011-01597, 2122870-2011-01598, 2122870-2011-01599, 2122870-2011-01600, AND 2122870-2011-01601.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CUSTOMER PRESENTED AT THE EMERGENCY ROOM. PER DATA PROVIDED BY THE CUSTOMER, THE PATIENT HAD HISTORICALLY ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS. AN ERRONEOUS, HIGH CARDIAC TROPONIN (ACCUTNI) RESULT WAS GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE SAME PATIENT SAMPLE RESULTS FOR CREATINE KINASE-MB ISOENZYME (CK-MB) AND B-TYPE NATRIURETIC PEPTIDE (BNP) WERE FOUND TO BE NORMAL. REPEAT ANALYSIS OF ADDITIONAL PATIENT DRAWS ON THE SAME DAY, AS WELL AS SUBSEQUENT DAYS, REPRODUCED ELEVATED ACCUTNI RESULTS. THE ERRONEOUS RESULTS WERE ALSO REPLICATED ON ANOTHER INSTRUMENT, AN ACCESS 2 IMMUNOASSAY SYSTEM. THE ACTUAL RESULTS GENERATED FROM THE ACCESS 2 IMMUNOASSAY SYSTEM WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THE RESULTS WERE ELEVATED ON BOTH INSTRUMENTS. IT IS UNKNOWN AS TO WHETHER THE RESULTS FROM THE ACCESS 2 IMMUNOASSAY SYSTEM WERE REPORTED OUT OF THE LABORATORY. THIS REPORT REPRESENTS THE RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM WITH SERIAL NUMBER 505095 ON DAY FOUR OF FOUR. RETESTING OF THE SAMPLES BY ANOTHER METHOD PRODUCED DISCORDANT, NEGATIVE RESULTS WHICH WERE CONSIDERED AS VALID. THE ACTUAL VALID RESULTS DATA WAS NOT PROVIDED BY THE CUSTOMER. THE INSTRUMENT WAS INDICATED AS PERFORMING WITHIN ACCEPTABLE QC SPECIFICATIONS. INSTRUMENT SYSTEM CHECKS DURING THE TIME OF THIS EVENT ALL MET INSTRUMENT SPECIFICATIONS. NO PHYSICAL SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE CUSTOMER DOES NOT BELIEVE THERE WAS A CHANGE IN PATIENT CARE ASSOCIATED WITH THIS EVENT BECAUSE THE PATIENT HAS A HISTORY OF ELEVATED TROPONIN RESULTS, HOWEVER IT IS UNKNOWN AS TO WHETHER THE ELEVATED ACCUTNI RESULTS WERE CONSIDERED IN INITIATING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R ACCESS ACCUTNI