BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1951738 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00082
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Removal / Correction Number
    Z-2887-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES. CHANGING REAGENT LOT RESOLVED THE ISSUE. SERVICE WAS NOT NEEDED FOR THIS EVENT AS THIS ISSUE IS REAGENT RELATED. 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 ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING WITH REAGENT OF DIFFERENT LOT PRODUCED NEGATIVE RESULTS. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE JQX BECKMAN COULTER, INC. IMMAGE 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1