BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2433877 · Received January 31, 2012

    Report

    Report Number
    2050012-2012-00312
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: FSE RETURNED THE SAMPLE SYRINGE ASSEMBLY. (B)(4)..

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2012 REPORTING OF A LEAK COMING FROM THE SAMPLE PROBE OF AN IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. CUSTOMER STATED THAT THE INSTRUMENT WAS SERVICED THE DAY BEFORE THE INCIDENT AND ALL QC AND PATIENT SAMPLES WERE GOOD WHEN THE FIELD SERVICE ENGINEER (FSE) HAD LEFT THE SITE. CUSTOMER STATED THAT NO PATIENT SAMPLES WERE RUN AND NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THE LEAK. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE LEAK AND NO EXPOSURE OR INJURY WAS REPORTED. FSE RETURNED ON 01/13/2012 AND REPLACED THE SAMPLE SYRINGE ASSEMBLY WITH A NEW ASSEMBLY. ISSUE WAS RESOLVED AND REPAIR WAS VERIFIED AS PER ESTABLISHED PROCEDURE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1