BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2132117 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02349
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JZJ
    PMA / PMN Number
    K962294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. CALIBRATION RESULTS FROM (B)(4) 2011 WERE ACCEPTABLE. QC RESULTS ON (B)(4) 2011 WERE OUT OF RANGE HIGH FOR IGG AND PAB FOR LEVEL 1. REPEAT TESTING BROUGHT THE RESULTS BACK WITHIN RANGE. NO OTHER CHEMISTRY ISSUES OR SYSTEM ERRORS WERE NOTED. ON (B)(4) 2011 A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND NOTED: QC IS WORKING PROPERLY. NO SIGNS OF HARDWARE ISSUES WERE NOTED. ADVISED THE CUSTOMER TO RUN PAB QC AT THE START OF THE DAY AND AT THE END F THE PATIENT RUN. NO ADDITIONAL ISSUES WERE REPORTED OR NOTED. ISSUE WAS RESOLVED BY RECALIBRATING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH PREALBUMIN (PAB) RESULTS GENERATED BY THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM NEPHELOMETER/IMMUNOCHEMISTRY SYSTEMS JZJ BECKMAN COULTER INC. IMMAGE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1