BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 4326754 · Received December 12, 2014

    Report

    Report Number
    1034569-2014-00231
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 20, 2014
    Report Date
    December 12, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING CONFIRMED THE PRESENCE OF THE E ANTIGEN ON CELLS 1, 3 AND 6 OF RETENTION CAPTURE-R READY-ID LOT ID231 MANUALLY AND ON THE ECHO. IN-HOUSE TESTING ALSO CONFIRMED THE PRESENCE OF THE E ANTIGEN ON CELLS 1, 3 AND 6 OF RETURNED PRODUCT ON THE ECHO. TESTING WAS PERFORMED USING RETENTION ANTI-E LOT 6F619-1 DILUTED 1:64 WITH RETENTION CAPTURE-R INDICATOR CELLS LOT 221259. CONTROLS PERFORMED AS EXPECTED. THERE WERE NO PRODUCT DEFICIENCIES IDENTIFIED. THE UNEXPECTED REACTIVITY APPEARS TO BE SAMPLE-RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-ID, LOT ID231.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807488 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID231

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR