BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2438310 · Received February 3, 2012

    Report

    Report Number
    2050012-2012-00336
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    NQD
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHECKED THE CUVETTES FOR CLEANLINESS AND CHECKED THE PROBES AND SYRINGES FOR LEAKS OR BUBBLES. THE CUSTOMER ALSO CHECKED THE CUVETTE WASH HEAD FOR SIGNS OF TEFLON PEELING, NO ISSUES WERE FOUND. ON (B)(4) 2012, A BECKMAN COULTER FIELD SERVICE ENGINEER IDENTIFIED THAT THE MIXER PADDLES WERE DIRTY AND REPLACED THEM. REAGENT PROBE WAS ALSO REPLACED FOR INCREASED OCCURRENCE OF LEVEL SENSE ERRORS. QUALITY CONTROL WAS PERFORMED AND WAS WITHIN RANGE. PROBABLE CAUSE WAS DETERMINED TO BE EITHER THE MIXER PADDLES OR THE REAGENT PROBE. AS OF (B)(4) 2012, THERE WERE NO FURTHER REPORTS OF THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW TEST RESULTS FOR C-REACTIVE PROTEIN (CRP) AND IMMUNOGLOBULIN G (IGG) WERE OBTAINED WHEN USING THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE TEST RESULTS WERE HIGHER UPON RETEST. BOTH ASSAYS WERE CALIBRATED BEFORE AND AFTER THE EVENT. QUALITY CONTROL WAS WITHIN RANGE BEFORE AND AFTER THE EVENT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. AMENDED REPORTS WERE ISSUED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR AFFECT TO PATIENT MANAGEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE NQD BECKMAN COULTER, INC. IMMAGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1