BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1071747 · Received July 9, 2008

    Report

    Report Number
    2122870-2008-00215
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE AND CENTRIFUGATION DATA WERE NOT SUPPLIED. SYSTEM CHECK AND QC INFO ON THE DATE OF THE EVENT WERE NOT SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE IN 2008: FSE NOTED THAT THE MIXER PULLEY AND TENSIONS WERE DIRTY AND WERE NOT MOVING FREELY AND REPLACED BOTH OF THEM. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. 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 ACCUTNI RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PT. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 0.70 NG/ML. UPON REPEAT, THIS SAMPLE GAVE 2 RESULTS OF 0.02 NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA