BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 8135344 · Received December 5, 2018

    Report

    Report Number
    1034569-2018-00272
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 5, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (1/27/03). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(4) 2018 TO ASSESS THE TESTING INSTRUMENT IN QUESTION. THE TEST WELL IMAGES IN QUESTION WERE VISUALLY NEGATIVE. BECAUSE THE PRODUCT WAS ALREADY EXPIRED, THE IMMUCOR LABORATORY SUBSEQUENTLY PERFORMED A DHR REVIEW, AND DETERMINED THAT THE PRODUCT HAD MET ALL NECESSARY SPECIFICATIONS AT THE TIME OF THE PRODUCT RELEASE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974935 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221196 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR