BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID EXTEND II

    MDR report key: 2022576 · Received March 17, 2011

    Report

    Report Number
    1034569-2011-00032
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS FILES: SAMPLE TESTED WITH CRRID EXTEND II LOT DN 045 RESULTED NEGATIVE ON ALL CELLS WHEN TESTED ON THE NEO. CONFIRMED THE REACTIVITY OF THE K ANTIGEN ON RETENTION CAPTURE-R READY-ID EXTEND, LOT DN045 USING ANTI-K QC#1 (1:256 DILUTION). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A SAMPLE WITH CAPTURE-R READY ID (CRRID) EXTEND II ON THE GALILEO NEO. THE SAMPLE WAS IDENTIFIED AS HAVING AN ANTI-K.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR