BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID EXTEND I

    MDR report key: 1920221 · Received December 10, 2010

    Report

    Report Number
    1034569-2010-00254
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    December 10, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW OF THE IMAGES RETRIEVED. ALL SAMPLES TESTED WERE VISUALLY NEGATIVE, NICE TIGHT BUTTON WITH NO RED CELL ADHERENCE. CONTROLS ACCEPTABLE ON BOTH SAMPLES TESTED ON THE PLATE. CUSTOMER HAS NOT EXPERIENCED THE REPORTED ISSUE AGAIN. CANNOT RULE OUT SAMPLE QUALITY AS THE CAUSE OF THE UNEXPECTED REACTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING SAMPLE WITH CAPTURE-R READY ID (CRRID) EXTEND I ON THE GALILEO. PATIENT IDENTIFIED TO HAVE AN ANTI-JKB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID EXTEND I REAGENT RED BLOOD CELLS KSZ IMMUCOR DP044A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR