BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2080778 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01493
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K962294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SYSTEM OR SPECIFIC SAMPLE ISSUES WERE NOTED. THE QC DATA WAS ACCEPTABLE AT THE TIME OF THE RUN OF THE SAMPLE. THE ISSUE APPEARS TO BE SAMPLE-SPECIFIC INTERFERENCE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT, AS THIS IS A SAMPLE RELATED ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A FALSELY HIGH RHEUMATOID FACTOR (RF) RESULT FOR ONE PATIENT THAT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE, GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER DHR BECKMAN COULTER INC. IMMAGE 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1