BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 16041119 · Received December 23, 2022

    Report

    Report Number
    1034569-2022-00019
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    June 21, 2022
    Report Date
    December 23, 2022
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001461
    PMA / PMN Number
    102707/5045
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022 THE 3_CELL ASSAY WAS PERFORMED BY IMMUCOR ON NEO 5030090014 USING RETENTION STRIPS OF CAPTURE-R READY-SCREEN 3 (CW) LOT E482 AND RETENTION VIAL OF CAPTURE-R READY INDICATOR RED CELLS LOT NUMBER 221085 WITH 6 KNOWN IN-HOUSE DONOR SAMPLES OF WHICH 3 WERE KNOWN NEGATIVE AND 3 WERE KNOWN POSITIVE (ANTI-(FY(A), ANTI- CW, ANTI-D). ALL SAMPLES REACTED AS EXPECTED. QC3_CELL PASSED AS EXPECTED. THE RETENTION PRODUCT PERFORMED AS EXPECTED. IN THIS INVESTIGATION, THE CUSTOMER ISSUE WAS NOT REPRODUCED OR CONFIRMED. RETENTION PRODUCT PERFORMED AS EXPECTED. NO PATIENT HARM WAS REPORTED. NO DEFECT OR DEFICIENCY WAS FOUND WITH THE CAPTURE-R READY-SCREEN 3 DEVICE; IT WAS DETERMINED THAT THE DEVICE WAS OPERATING AS DESIGNED AND WITHIN THE KNOWN LIMITATIONS DESCRIBED IN LABELING. NO REMEDIAL ACTION IS REQUIRED. THE EVENT HAS BEEN ATTRIBUTED TO THE SAMPLE, WHERE THE ANTIBODIES DETECTED BY GELCARD TECHNOLOGY APPEAR TO BE WHOLLY IGM IN NATURE; AND ANY IGG COMPONENT OF THE ANTIBODIES OCCURS BELOW THE DETECTION CAPABILITY OF CAPTURE-R READY-SCREEN 3. THE FOLLOWING LIMITATIONS REGARDING THE SPECIMEN APPLY AS DESCRIBED IN THE INSTRUCTIONS FOR USE FOR CAPTURE-R READY-SCREEN 3 (IFU 387-5) : SPECIFICITIES OF PRESUMED SIGNIFICANCE, THAT ARE WHOLLY IGM IN NATURE (IE, IGM ANTI-K OR IGM ANTI-E) MAY FAIL TO REACT IN THIS ASSAY. ACCORDING TO "THE BLOOD GROUP ANTIGEN FACTS BOOK. M.E. REID ETAL., ELSEVIER 2022" ALLOANTI-CW AS WELL AS ALLOANTI-FY(B) CAN OCCUR AS IGM ANTIBODIES. NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED. THE INTERNAL IMMUCOR REFERENCE FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2022 A CUSTOMER SITE IN THE UK REPORTED THAT THEY HAD RECEIVED UNEXPECTED NEGATIVE RESULTS FOR AN ANTIBODY SCREEN USING CAPTURE-R READY-SCREEN 3 ON THE EUROPEAN VERSION OF THE NEO IRIS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591015 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. CAPTURE-R READY-SCREEN 3 E428 10888234001461

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown