BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1904806 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01313
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    November 17, 2010
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A1M IS MEASURED IN URINE SAMPLES. QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A NEW LOT OF URINE CALIBRATOR WAS USED TO CALIBRATE THE SYSTEM, WHICH RESOLVED THE PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW ALPHA-1-MICROGLOBULIN (A1M) ON TWO PATIENT SAMPLES THAT WERE GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. NO FALSE RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT SAMPLES WERE REPEATED AND WERE REPORTED. THERE WAS NO AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    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