BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1961745 · Received January 14, 2011

    Report

    Report Number
    2050012-2011-00157
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    Z-2887-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS WERE NOT SUPPLIED BY THE CUSTOMER TO DATE. UPON CHANGING THE REAGENT THE ISSUE WAS RESOLVED. SERVICE WAS NOT REQUESTED FOR THIS EVENT, AS THIS WAS A REAGENT ISSUE. INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE IS ONGOING.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ...

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY HIGH RHEUMATOID FACTOR (RF) RESULTS THAT WERE GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS UNKNOWN HOW MANY RESULTS, WHAT THE LEVELS WERE, AND WHETHER THERE HAVE BEEN ANY PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. IMMAGE 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1