BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 12879735 · Received November 27, 2021

    Report

    Report Number
    1034569-2021-00029
    Event Type
    Malfunction
    Date Received
    November 27, 2021
    Date of Event
    October 9, 2021
    Report Date
    November 26, 2021
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234001454
    PMA / PMN Number
    BL 102707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMMUCOR RECEIVED 1 TUBE WITH 2.0 ML PLASMA AND 1 TUBE WITH 0.5 ML RED CELLS. BOTH TUBES WERE LABELED (B)(6). ON (B)(6) 2021 IMMUCOR CONFIRMED PRESENCE OF THE K ANTIGEN ON CELL 1 OF RETENTION CAPTURE R READY SCREEN LOT R292 BY CAPTURE METHOD CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221886 WITH RETENTION ANTI-K LOT 054020. CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. ON (B)(6) 2021 IMMUCOR CONFIRMED PRESENCE OF THE C ANTIGEN ON CELL 1 OF RETENTION CAPTURE R READY SCREEN LOT R292 IN MANUAL CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221886 WITH RETENTION ANTI-C LOT DL23472. CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. ON (B)(6) 2021 IMMUCOR CONFIRMED PRESENCE OF THE E ANTIGEN ON CELL 2 OF RETENTION CAPTURE R READY SCREEN LOT R292 BY CAPTURE METHOD CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221886 WITH RETENTION ANTI-E LOT 053020. CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. ON (B)(6) 2021 IMMUCOR CONFIRMED PRESENCE OF THE S ANTIGEN ON CELLS 1 AND 2 OF RETENTION CAPTURE R READY SCREEN LOT R292 BY CAPTURE METHOD CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221886 WITH RETENTION ANTI-S LOT 622008-AA CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. ON (B)(6) 2021 IMMUCOR CONFIRMED PRESENCE OF THE FYA ANTIGEN ON CELLS 1 AND 2 OF RETENTION CAPTURE R READY SCREEN LOT R292 BY CAPTURE METHOD CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221886 WITH RETENTION ANTI-FYA LOT 055020. CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. ON (B)(6) 2021 IMMUCOR PERFORMED AN ANTIBODY SCREEN ON THE ECHO LUMENA WITH RETURN SAMPLE (B)(6) SAMPLE USING RETENTION CAPTURE R READY SCREEN LOT R292 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221886. CONTROLS PERFORMED AS EXPECTED AND RETURN SAMPLE (B)(6) RESULTED 1+ POSITIVE WITH CELL 2 (E+E=). ON (B)(6) 2021 IMMUCOR PERFORMED AN ANTIBODY ID ON THE ECHO LUMENA WITH RETURN SAMPLE (B)(6) SAMPLE USING RETENTION CAPTURE R READY ID LOT ID422 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221886. CONTROLS PERFORMED AS EXPECTED AND RETURN SAMPLE (B)(6) RESULTED 1+ POSITIVE WITH CELL 3 (E+E=) AND NEGATIVE WITH CELL 1 (E+E+) AND CELL6 (E+E+). THERE ARE NO ADDITIONAL COMPLAINTS OF UNEXPECTED NEGATIVE REACTIVITY FOR CAPTURE R READY SCREEN LOT R292. THE INTERNAL IMMUCOR RECORD FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 0

    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 V2.0 INSTRUMENT AND A DELAYED TRANSFUSION REACTION WITH ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777568 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. R292 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female