BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 717563 · Received August 31, 2005

    Report

    Report Number
    2122870-2005-00127
    Event Type
    Other
    Date Received
    August 31, 2005
    Date of Event
    August 8, 2005
    Report Date
    August 31, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DPZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS FROM THREE (3) DIFFERENT PTS THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. THE CUSTOMER INDICATED THAT THE ELEVATED ACCU TNI RESULTS WERE: 2.44NG/ML, 0.76NG/ML, AND 0.67NG/ML FOR PTS A TO C RESPECTIVELY. THE ACCU TNI RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT AFTER THE INITIAL RESULTS WERE OBTAINED, PT A WAS REDRAWN TWICE; THE ACCU TNI RESULTS WERE 0.01NG/ML FROM BOTH SAMPLES. PT B WAS REDRAWN ONCE; THE RESULT WAS 0.06NG/ML. THE CUSTOMER INDICATED THAT A PHYSICIAN QUESTIONED THE ACCU TNI RESULT FOR PT C. THE PT C ORIGINAL SAMPLE WAS RE RE-TESTED FOR ACU TNI; THE RESULT WAS 0.00NG/ML. THE CUSTOMER THAN REPEATED THE PTS A AND B ORIGINAL SAMPLES FOR ACCU TNI. THE REPEATED ACCU TNI RESULTS WERE: 0.02NG/ML FOR PT A AND 0.00NG/ML FOR PT B. THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PT TREATMENT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA