BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2030096 · Received March 26, 2011

    Report

    Report Number
    2050012-2011-00868
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE TYPE FOR THIS ASSAY IS RANDOM URINE. NO SAMPLE ISSUES ARE NOTED. CUSTOMER HAS INDICATED THAT QC RESULTS ARE WITHIN EXPECTED RANGE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED BY FIELD SERVICE AND TECHNICAL SUPPORT. NO ROOT CAUSE IS KNOWN AT THIS TIME AS THE ISSUE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRATIC MICROALBUMIN (MA) RESULTS THAT WERE NOT REPORTED OUT OF THE LABORATORY FOR SEVERAL SAMPLES, GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE CUSTOMER PROVIDED EXAMPLES OF THE RESULT SAMPLES FOR THIS EVENT. THE CUSTOMER INDICATED THAT THERE HAS BEEN NO AFFECT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1