BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID EXTEND I

    MDR report key: 8434279 · Received March 19, 2019

    Report

    Report Number
    1034569-2019-00060
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 20, 2019
    Report Date
    March 19, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234000662
    PMA / PMN Number
    102707/5030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(4) 2019 TO ASSESS THE TESTING INSTRUMENT IN QUESTION, AND FOUND THE TEST IMAGES IN QUESTION WERE VISUALLY NEGATIVE. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON BOTH (B)(4) 2019 (FOR K ANTIGEN STATUS), AND (B)(4) 2019 (FOR C ANTIGEN STATUS), AND FOUND THE RETENTION PRODUCT TO BE PERFORMING AS EXPECTED. THE IMMUCOR LABORATORY ALSO RECEIVED A BLOOD SAMPLE FROM THE CUSTOMER SITE ((B)(6)) AND TESTED IT WITH RETENTION OF DP106 AND 221275, AND THE OUTCOME WAS NEGATIVE WITH THE CUSTOMER'S BLOOD SAMPLE, WHICH REPRODUCED THE CUSTOMER'S OBSERVATION. THE INTERNAL IMMUCOR RECORD TRACKING NUMBER IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227131 CAPTURE-R READY-ID EXTEND I REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. DP106 10888234000662

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR