BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1911189 · Received November 30, 2010

    Report

    Report Number
    2050012-2010-01475
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERA. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. OTHER RESULTS WERE SUPPRESSED. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010 AND REPLACED THE SYRINGES AND THEN RETURNED ON (B)(4) 2010 TO REPLACE THE VACUUM VALVE. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS RESULTS GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM FOR THREE PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED DIFFERENT RESULTS. THERE WAS NO EFFECT TO THE PATIENTS OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1