BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 16679202 · Received April 4, 2023

    Report

    Report Number
    1034569-2023-00008
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    February 17, 2023
    Report Date
    April 4, 2023
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6), 2023, IMMUCOR USED REMOTE ACCESS TO VIEW THE RESULTS OF THE RELEVANT TESTS. IMAGES WERE REVIEWED FOR CAPTURE-R READY-SCREEN 3 ASSAY ON (B)(6) 2023. THIS SAMPLE HAD BUTTONS THAT WERE TIGHTLY DEFINED AND DENSE FOR WELLS 1-3. WELLS 1 AND 3 HAD VERY SLIGHT ADHERENCE WITH WELL 3 EXHIBITING MORE ADHERENCE THAN THE OTHER WELLS. THE REACTION IMAGES WERE ANALYZED AND WELL 3 WAS ON THE THRESHOLD OF DETECTION DUE TO THE SIZE OF THE BUTTON WITH RESPECT TO THE BACKGROUND. IMAGES FOR THE CAPTURE-R READY-ID ASSAY ON (B)(6) 2023 WERE ALSO REVIEWED; AND ALL WELLS HAVE TIGHTLY DEFINED AND DENSE CELL BUTTONS. WELLS 7 AND 8 HAVE VERY SLIGHT ADHERENCE. WELL 13 HAS A SMALLER DEFINED CELL BUTTON AND SLIGHT ADHERENCE, AN EQUIVOCAL REACTION. IMAGES REVIEWED IN THIS COMPLAINT WERE AS EXPECTED WITH RESPECT TO THE INTERPRETATION ON THE INSTRUMENT. IT IS SUSPECTED THAT THE PATIENT HAD A NEWLY FORMED ANTI-K AS A RESULT OF A RECENT PREVIOUS TRANSFUSION (I.E. PRIOR TO (B)(6) 2023). THIS NEWLY FORMED ANTIBODY MAY HAVE BEEN MOSTLY OR WHOLLY IGM IN NATURE, SUCH THAT ANY IGG COMPONENT WAS BELOW THE LEVEL OF DETECTION OF THE ASSAYS. THE INTENDED USE OF THE CAPTURE PRODUCTS IS DETECTION OF IGG ANTIBODIES; AND THE IFU'S CITE THE FOLLOWING APPLICABLE LIMITATION "SPECIFICITIES OF PRESUMED SIGNIFICANCE, THAT ARE WHOLLY IGM IN NATURE (I.E., IGM ANTI-K OR IGM ANTI-E) MAY FAIL TO REACT IN THIS ASSAY". ON (B)(6) 2023, IMMUCOR CONFIRMED PRESENCE OF THE K ANTIGEN ON CELL 3 OF RETENTION CAPTURE-R READY-SCREEN 3 LOT R451 BY CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL LOT 221232 WITH RETENTION ANTI-K LOT 054035. CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. NO DEFECT OR DEFICIENCY WAS IDENTIFIED FOR EITHER THE INSTRUMENT OR THE ASSAY REAGENTS. THIS IS A SAMPLE RELATED ISSUE. THE INTERNAL IMMUCOR REFERENCE FOR THIS EVENT IS PR#954447.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A CUSTOMER STATED THAT A PATIENT HAD A TRANSFUSION REACTION FOLLOWING RECEIPT OF ONE UNIT OF K+ BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257306 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. R451 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male