BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 11953906 · Received June 8, 2021

    Report

    Report Number
    1034569-2021-00017
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 8, 2021
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234001454
    PMA / PMN Number
    BL 102707
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021 AN IMMUCOR FIELD SERVICE ENGINEER INSPECTED ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(4) AT THE CUSTOMER SITE. THE IMMUCOR FIELD SERVICE ENGINEER PERFORMED AN UNEXPECTED REACTION CHECKLIST. IMMUCOR ADVISED CUSTOMER THAT THE ISSUE APPEARS TO BE SAMPLE RELATED. CUSTOMER ADVISED OF THE FOLLOWING LIMITATION 12 IN THE PACKAGE INSERT: SOME IGG ANTIBODIES HAVE BEEN SHOWN TO REACT POORLY IN SOLID PHASE RED BLOOD CELL ADHERENCE ASSAYS. THESE INCLUDE EXAMPLES OF ANTIBODIES TO BGA, BGB, KNA, CSA, YKA, JMH, MCCA, CH AND RG. THE INTERNAL IMMUCOR RECORD FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021 A CUSTOMER REPORTED THAT A PATIENT HAD A SUSPECTED FEBRILE HEMOLYTIC REACTION WHEN RECEIVING PART OF ONE BLOOD UNIT THAT WAS ELECTRONICALLY CROSS MATCHED BASED ON NEGATIVE ECHO LUMENA SCREEN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857365 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. R236 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR