BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 1862402 · Received October 8, 2010

    Report

    Report Number
    1034569-2010-00215
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 8, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ADJUSTED PROBES (NEEDLE POSITION) ON THE CSW100 THAT WAS USED DURING INITIAL TESTING. SAME PATIENT SAMPLE WAS RETESTED. THE EXPECTED POSITIVE RESULTS WERE OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FOR ANTI-K WHEN TESTING A PATIENT SAMPLE MANUALLY WITH CAPTURE-R READY SCREEN 3 USING THE CSW100 (SERIAL# (B)(4)) TO WASH THE PLATES. CUSTOMER ALSO STATED THAT THE METAL PROBE ON THE WASHER WAS HITTING AGAINST THE SIDE OF THE STRIP DURING WASHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR R113

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR