BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3953575 · Received July 23, 2014

    Report

    Report Number
    1034569-2014-00131
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 23, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES. AN IMMUCOR FIELD SERVICE ENGINEER IDENTIFIED THE SAMPLE IN QUESTION ON (B)(6) 2014 WHEN VISITING THE CUSTOMER SITE TO ASSESS THE INSTRUMENT. THE BLOOD SAMPLE IN QUESTION WAS RETURNED TO THE IMMUCOR LABORATORY FOR INVESTIGATION, WHICH REPRODUCED THE CUSTOMERS ISSUE WHEN TESTED ON (B)(6) 2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN IMMUCOR FIELD SERVICE ENGINEER IDENTIFIED THE SAMPLE IN QUESTION WHEN VISITING THE CUSTOMER SITE TO ASSESS ONGOING PROBLEMS WITH THE TESTING INSTRUMENT AND REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) USING A GALILEO ECHO INSTRUMENT. THE PROBLEMS OF INCONSISTENT REACTIONS DATE BACK TO (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430770 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R436

    Patients

    Seq Age Sex Outcome Treatment
    1