BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1982922 · Received February 9, 2011

    Report

    Report Number
    2122870-2011-00364
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES AFTER THE ERRONEOUS RESULTS. A SYSTEM CHECK WAS PERFORMED ON 01/06/2011 AND MET SPECIFICATIONS. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER IS NOT QUESTIONING THE INSTRUMENT PERFORMANCE BUT REPRODUCIBLE RESULTS ON ONE PATIENT. ALTHOUGH AN INTERFERENT IN THE PATIENT'S SAMPLE IS SUSPECTED, NO ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF FOR ONE PATIENT THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT'S SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND WAS ALSO ELEVATED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED DUE TO THE ELEVATED ACCUTNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1