BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV INDICATOR CELLS

    MDR report key: 2260571 · Received September 22, 2011

    Report

    Report Number
    1034569-2011-00142
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 22, 2011
    Report Date
    September 22, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE GALILEO NEO IMAGE FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST AND FOUND THAT FOUR TEST WELLS HAD PARTIAL BUTTONS SURROUNDED BY DIFFUSION. THE TEST WELL FILL IMAGES WERE ALSO REVIEWED AND APPEARED TO HAVE NUMEROUS BUBBLES THROUGHOUT THE PLATE. THE GALILEO IMAGE FILES WERE REVIEWED AND ALL TEST WELLS VISUALLY APPEARED NEGATIVE. AN IMMUCOR FIELD SERVICE ENGINEER INSPECTED CAMERA IMAGES FOR RESULTS IN QUESTION USING ISTAR. NO ROI ADJUSTMENTS WERE NEEDED. TEST WELL FILL IMAGES FOR EFFECTED PLATE AND OTHERS FROM SAME DAY OF TESTING SHOWED BUBBLES IN VARIOUS WELLS. THE INSTRUMENT WAS PRIMED AND AIR BUBBLES WERE BEING DRAWN INTO THE REAGENT SYRINGE. THE REAGENT SYRINGE WAS REMOVED AND RE-TIPPED. THE INSTRUMENT WAS AGAIN PRIMED AND NO BUBBLES WERE SEEN IN ANY LINES OR SYRINGES. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WHILE VALIDATING THE GALILEO NEO INSTRUMENT, POSITIVE RESULTS WERE OBTAINED ON THE CMV ASSAY FOR FOUR SAMPLES THAT WERE NEGATIVE ON THE GALILEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-CMV INDICATOR CELLS SOLID PHASE SYSTEM FOR DETECTION OF IGG AND IGM ANTIBODIES TO CYTOMEGALOVIRUS KSZ IMMUCOR, INC. 228154

    Patients

    Seq Age Sex Outcome Treatment
    1