BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 623104 · Received July 26, 2005

    Report

    Report Number
    2122870-2005-00109
    Event Type
    Other
    Date Received
    July 26, 2005
    Date of Event
    June 29, 2005
    Report Date
    July 26, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULTS ON 2 DIFFERENT PTS THAT WERE GENERATED BY THE ACCESS IMMUNOASSAY SYSTEM INSTRUMENT. THE ACCU TNI RESULT FOR PT A WAS 0.36 UG/L AND 3.3 UG/L. THE ACCU TNI RESULT FOR PT B WAS >200 UG/DL, 148.85 UG/L AND 1.8 UG/L. IT IS UNKNOWN IF THE ELEVATED ACCU TNI RESULTS FOR BOTH PATIENT A AND B WERE REPORTED OUT OF THE LAB. IT IS UNKNOWN AT THIS TIME WHAT THE CORRECT RESULTS ARE. THE CUSTOMER INDICATED THAT THE ORIGINAL SAMPLE FROM PT B WAS RETESTED FOR ACCU TNI. THE REPEATED ACCU TNI RESULT FOR PT B WAS 160 UG/DL. NO OTHER INFO WAS PROVIDED FROM THE CUSTOMER. THERE HAS BEEN NO CHANGE TO PT TREATMENT OR ANY INJURY THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other