BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 413177 · Received August 21, 2002

    Report

    Report Number
    2122870-2002-00019
    Event Type
    Other
    Date Received
    August 21, 2002
    Date of Event
    July 24, 2002
    Report Date
    August 20, 2002
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002 CUSTOMER REPORTS THAT AN ERRONEOUS ELEVATED ACCU TNI WAS REPORTED OUT OF THE LAB. (2.09 NG/MI). THIS WAS THE FIRST SAMPLES DRAWN ON A PATIENT IN THE ER. CKMB RESULTS WERE NORMAL (NOT GIVEN) AND TOTAL CK (182) WAS IN THE NORMAL RANGE. THE PATIENT HAD A CARDIAC CATHETERIZATION PROCEDURE PERFORMED. THE PHYSICIAN QUESTIONED THE ELEVATED ACCUTNI RESULT. THE SAMPLE WAS REPEATED IN 7/2002 AFTER THE INSTRUMENT WEEKLY MAINTENANCE WAS PERFORMED. THE REPEAT RESULT WAS IN THE NORMAL RANGE (0.06 NG/ML). THE PATIENT HAD A SECOND SAMPLE COLLECTED 12 HOURS AFTER THE ER SAMPLE. NO ACCUTNI WAS RUN. CKMB WAS NORMAL AT 1.4 AND TOTAL CK WAS NORMAL AT 105. CUSTOMER HAD REQUESTED FROM THE PATHOLOGIST TO FIND OUT IF THE CATHETERIZATION WAS PREFORMED SOLELY ON THE SINGLE ACCUTNI RESULT, OR IF THE PHYSICIAN WOULD HAVE PERFORMED THE PROCEDURE REGARDLESS OF THE RESULT. AS OF TODAY, THAT INFORMATION HAS NOT BEEN PROVIDED TO COMPANY. THE COMPANY HAS NOT RECEIVED ANY REPORTS OF ADVERSE OUTCOMES TO THE PATIENT. ACCUTNI IS NOT RECOMMENDED AS A STAND-ALONE CARDIAC MARKER AND SERIAL SAMPLES ARE RECOMMENDED. ACCUTNI IS NOT INDICATED AS THE SOLE DETERMINANT OF AMI. THE ACCUTNI RESULT SHOULD BE EVALUATED AS PART OF THE TOTAL CLINICAL PICTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other