BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 7024774 · Received November 13, 2017

    Report

    Report Number
    1034569-2017-00303
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 14, 2017
    Report Date
    November 13, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS PMA/510 (K)# BK020053 (1/27/03). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(6) 2017 TO ASSESS THE INSTRUMENT TEST WELL IMAGE IN QUESTION, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGE IN QUESTION WAS VISUALLY NEGATIVE. AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO ASSESS THE TESTING INSTRUMENT USED ON (B)(6) 2017 AND FOUND IT TO BE OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803102 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221957 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR