BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELL

    MDR report key: 8808940 · Received July 19, 2019

    Report

    Report Number
    1034569-2019-00119
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 19, 2019
    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

    ON (B)(6) 2019 IMMUCOR PERFORMED AN ANTIBODY SCREEN QC ON AN ECHO LUMENA USING RETENTION CAPTURE-R READY-SCREEN 3 LOT NUMBER R068 AND RETENTION CAPTURE-R INDICATOR CELLS LOT NUMBER 221345. CONTROLS PERFORMED AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. THE IMMUCOR INTERNAL RECORD NUMBER FOR THIS REPORT IS (B)(4). .

    Description of Event or Problem · 1

    ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN AND ID RESULTS ON THE ECHO LUMENA INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600738 CAPTURE-R READY INDICATOR CELL QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS KSF IMMUCOR, INC. 221345 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR