BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 580963 · Received March 10, 2005

    Report

    Report Number
    2122870-2005-00027
    Event Type
    Other
    Date Received
    March 10, 2005
    Date of Event
    February 12, 2005
    Report Date
    March 10, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONTACTED REGARDING AN ELEVATED ACCU TNL RESULT FROM A PATIENT THAT WAS GENERATED BY THE UNICEL DXL INSTRUMENT. PATIENT WAS BEING MONITORED USING TROPONIN (ACCU TNL) DUE TO A CLINICAL SUSPICION OF A CARDIAC EVENT. THE PATIENT HAD AN ACCU TNL RESULT OF 0.04UG/L FROM A PREVIOUS SAMPLE (A). THE ELEVATED ACCU TNL (SAMPLE B) RESULT WAS 0.64UG/L. THE ELEVATED ACCU TNL RESULT (FROM SAMPLE B) WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT A NEW SAMPLE (C) WAS COLLECTED FOR ACCU TNL. THE ACCU TNL RESULT FROM SAMPLE C WAS 0.04UG/L. BASED ON THE LOWER ACCU TNL RESULT FROM SAMPLE C, THE CUSTOMER RETESTED SAMPLE B FOR ACCU TNL. THE REPEATED ACCU TNL RESULT FROM SAMPLE B WAS 0.04UG/L. THE CUSTOMER DID NOT INDICATE IF A CORRECTED REPORT WAS SENT FOR SAMPLE B. THERE HAS BEEN NO PATIENT INJURY THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other