BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 12566238 · Received October 2, 2021

    Report

    Report Number
    1034569-2021-00024
    Event Type
    Malfunction
    Date Received
    October 2, 2021
    Date of Event
    September 25, 2021
    Report Date
    October 1, 2021
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234001454
    PMA / PMN Number
    BL 102707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR OFFERED TO HAVE AN IMMUCOR FIELD SERVICE ENGINEER INSPECT THE INSTRUMENT AND PERFORM REACTIONS CHECKLIST, BUT CUSTOMER DECLINED AND STATED THAT THIS IS A SAMPLE RELATED ISSUE. NO PRODUCT OR SAMPLE WAS RETURNED TO IMMUCOR FOR FURTHER INVESTIGATION. THE INTERNAL IMMUCOR RECORD FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT FOR PRE-TRANSFUSION SAMPLE WITH USING CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT AND A HEMOLYTIC TRANSFUSION REACTION WITH ONE PATIENT. CUSTOMER STATED THAT THIS IS A SAMPLE RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464083 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. R279 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR