BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 8029563 · Received November 1, 2018

    Report

    Report Number
    1034569-2018-00248
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    September 10, 2018
    Report Date
    November 1, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (JANUARY 27, 2003). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(6) 2018 TO ASSESS THE TESTING INSTRUMENT IN QUESTION. THE IMMUCOR LABORATORY HAD PREVIOUSLY TESTED RETENTION PRODUCT ON (B)(6) 2018, WHICH PERFORMED AS EXPECTED AT THAT TIME. THE INTERNAL IMMUCOR RECORD TRACKING NUMBER FOR THIS RECORD IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED TO IMMUCOR TECHNICAL SUPPORT, ON BEHALF OF A CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871309 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221158 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR