BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 8912027 · Received August 20, 2019

    Report

    Report Number
    1034569-2019-00130
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 23, 2019
    Report Date
    August 20, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS FILES ON GALILEO ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(4); NO ERRORS WERE SEEN DURING TESTING AND THE CAMERA REPORT WAS WITHIN SPECIFICATION. ON JULY 23, 2019 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS FILES ON GALILEO ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(4); NO ERRORS WERE SEEN DURING TESTING AND THE CAMERA REPORT WAS WITHIN SPECIFICATION. ON JULY 26, 2019 IMMUCOR CONFIRMED PRESENCE OF THE K ANTIGEN ON CELL 3 OF RETENTION CAPTURE-R READY-SCREEN LOT NUMBER R076 IN MANUAL CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221357 WITH RETENTION ANTI-K LOT K012512F-2. CONTROLS PERFORMED AS EXPECTED. CELL 3 RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. THE IMMUCOR INTERNAL REPORT RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULTS WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO ECHO V2.0 INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703933 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R076 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1