BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1018092 · Received March 14, 2008

    Report

    Report Number
    2122870-2008-00084
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO PROVIDED, THE CUSTOMER'S QC WAS WITHIN SPECS. THE ELEVATED RESULTS WERE REPEATABLE, AND DILUTION OF THE SAMPLE DID NOT DILUTE LINEARLY. NO ADD'L INFO REGARDING THIS EVENT IS AVAIL. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE AS THE SAMPLE CANNOT BE SENT OUT OF ANOTHER COUNTRY TO BECKMAN COULTER INC. (BCI) FOR HETEROPHILE INVESTIGATION TESTING. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

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

    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