BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1931228 · Received December 17, 2010

    Report

    Report Number
    1034569-2010-00259
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 14, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS FILES DISPLAYED NEGATIVE REACTION WITH CRRID CELLS 1-14, CELLS 1, 3, 6, 7 ARE E+ AND APPEARED AS WEAK POSITIVE REACTIONS WITH A SLIGHTLY FUZZ BUTTON AND A SMALL AMOUNT OF ADHERENCE AND WERE INTERPRETED AS NEGATIVE ON THE ECHO. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN TECHNICAL COMMUNICATION CC-09-042-02 ON (B)(6) 2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO. A PATIENT WITH A HISTORY OF AN ANTI-E RESULTED AS NEGATIVE WITH ALL E+ POSITIVE CELLS ON CAPTURE-R READY ID (CRRID) LOT ID132. TESTING PERFORMED ON ANOTHER DATE RESULTED AS EXPECTED. A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED AND RESULTED UNEXPECTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR ID132

    Patients

    Seq Age Sex Outcome Treatment
    1