BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID EXTEND II

    MDR report key: 1862764 · Received October 8, 2010

    Report

    Report Number
    1034569-2010-00213
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 7, 2010
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS:CRRID EXTEND II - REACTION IMAGE WITH CELL 11 APPEARED WEAK POSITIVE WITH A LOOSE BUTTON AND A SMALL AMOUNT OF ADHERENCE. REACTION SCORE WAS 0. CUSTOMER DID NOT RETURN SAMPLE OR PRODUCT FOR TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTION WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY ID (CRRID) EXTEND II ON THE ECHO. THE PATIENT HAS A NEWLY DEVELOPING (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID EXTEND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. DN042

    Patients

    Seq Age Sex Outcome Treatment
    1