BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2823379 · Received November 7, 2012

    Report

    Report Number
    2050012-2012-01827
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT AND OBSERVED THAT THE LEAK WAS ATTRIBUTED TO THE PROBE WASH STATION FILTER. THE FSE REPLACED THE FILTER AND NO FURTHER LEAKING OR OTHER PROBLEMS WERE OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    FILTERS WERE RETURNED TO BEC FOR FURTHER INVESTIGATION AND THE COMPLAINT WAS VERIFIED. PER THE FAILURE INVESTIGATION REPORT (FIR) ANALYSIS, THE TWO FILTERS WERE RECEIVED BY THE LABORATORY ON (B)(6) 2012. ONE WAS LABELED 'GOOD' AND ONE WAS LABELED 'BAD'. A VISUAL EXAMINATION WAS DONE AND THE LABELED 'BAD' IS CLOGGED AT THE CENTER. THE 'GOOD' FILTER IS NOT CLOGGED. NO FURTHER TESTING WAS DONE ON THE FILTER.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THERE WAS A FLUID LEAK OF APPROXIMATELY 5 ML OF FLUID IN VOLUME UNDER THE REAGENT PROBE IN THE IMAGE IMMUNOCHEMISTRY SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE LEAK APPEARS TO BE WASH/BUFFER SOLUTION. THE CUSTOMER WAS WEARING GLOVES AND EYE PROTECTION WHEN THE LEAK WAS DISCOVERED. THE OPERATOR WAS UNABLE TO SUCCESSFULLY TROUBLESHOOT THE ISSUE. SERVICE REQUEST WAS INITIATED. THERE WERE NO ERRONEOUS RESULTS GENERATED OR REPORTED DUE TO THIS INCIDENT. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. IMMAGE 120V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1