BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 16587906 · Received March 21, 2023

    Report

    Report Number
    1034569-2023-00007
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 21, 2023
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234000648
    PMA / PMN Number
    102707/0.0
    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 REVIEW IMAGES FROM M20401 FOR SAMPLE (B)(6). 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 REVIEWED IN THIS COMPLAINT WERE AS EXPECTED WITH RESPECT TO THE INTERPRETATION ON THE INSTRUMENT. ON (B)(6) 2023 IMMUCOR PERFORMED A SCREEN ASSAY ON THE ECHO LUMENA USING 2 KNOWN ANTIBODY NEGATIVE IN HOUSE DONOR SAMPLES WITH RETENTION CRRS3 LOT R451 AND RETENTION CRRIRC LOT 221215. THIS TESTING WAS TO SHOW THAT NO NON-SPECIFIC REACTIVITY WAS TAKING PLACE ON THE PLATE. CONTROLS PERFORMED AS EXPECTED, AND THE 2 IN HOUSE SAMPLES RESULTED NEGATIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. IDENTIFIED ANTI-K WAS WEAKLY EXPRESSED (1+) AND MAY BE NEWLY FORMED (RESULTING FROM MULTIPLE PAST TRANSFUSIONS) OR LARGELY IGM IN NATURE (CAPTURE TECHNOLOGY DOES NOT RELIABLE DETECT IGM; INTENDED USE IS DETECTION OF IGG). THE INTERNAL IMMUCOR REFERENCE FOR THIS EVENT IS PR#: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2023 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY (MISSED ANTI-K) WITH CAPTURE-R READY-SCREEN 3 ON THEIR ECHO LUMENA INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938141 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. R451 10888234000648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown