BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 951552 · Received November 15, 2007

    Report

    Report Number
    2122870-2007-00266
    Event Type
    Other
    Date Received
    November 15, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 15, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A BD, LITHIUM HEPARIN TUBE AND WAS CENTRIFUGED AT 3,105 RPM FOR 10 MINUTES. QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK FAILED PARTIALLY AND MET SPECIFICATIONS WHEN THE FAILED PORTION ONLY WAS REPEATED. A SYSTEM CHECK PERFORMED ONE WEEK LATER WAS WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) TO THE INSTRUMENT. THE FSE RAN DIAGNOSTIC AND PRECISION TESTING AND RESULTS WERE WITHIN SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNL) RESULT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR ACCU TNL AND A RESULT OF 1.43NG/ML WAS OBTAINED. THE SAMPLE WAS RE-TESTED AND THE REPEATED ACCU TNL RESULT WAS 0.10NG/ML. BOTH RESULTS WERE REPORTED OUT OF THE LAB DUE TO THE INITIAL RESULT NOT MEETING THE CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED 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 JJE BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR