BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1938283 · Received December 27, 2010

    Report

    Report Number
    2050012-2010-01695
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 28, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS USING REAGENT LOT M911529 AND M912354, AND THE ISSUE WAS RESOLVED UPON CHANGING THE REAGENT LOT. THE CUSTOMER INDICATED THE INSTRUMENT STATUS WAS CHECKED AND DID NOT REQUIRE SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 NOT REPORTED OUT OF THE LABORATORY BECAUSE THE POSITIVE CUTOFF WAS ADJUSTED. THE CUSTOMER INDICATED THE PERCENTAGE OF SAMPLES READING RF RESULTS BETWEEN 20 IU/ML AND 25 IU/ML HAS INCREASED FROM ABOUT 5% TO 45% ONCE THE CURRENT LOTS OF RF REAGENT WERE IN USE. THERE WAS NO EFFECT TO THE PATIENTS.

    Description of Event or Problem · 1

    ...

    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