BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CAPTURE-CMV

    MDR report key: 23442464 · Received October 31, 2025

    Report

    Report Number
    1034569-2025-00027
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Report Date
    October 31, 2025
    Manufacturer
    IMMUCOR, INC.
    Product Code
    MZE
    UDI-DI
    10888234002154
    PMA / PMN Number
    BK200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO COMMON SPECIFIC ROOT CAUSE OR DEFECT WAS IDENTIFIED. THE CONCLUSION(S) CODE(S) REPORTED HEREIN ARE ASSIGNED ACCORDING TO THE FACTS PRESENTED BY THE AFFECTED CUSTOMER AND IMMUCOR'S ASSESSMENT AND INVESTIGATION OF THOSE FACTS. WHEN POSSIBLE, IMMUCOR ATTEMPTS TO OBTAIN THE ACTUAL SAMPLES AND REAGENTS INVOLVED; RETENTION REAGENTS OF THE SAME LOT THAT WAS INVOLVED IN THE EVENT MAY BE USED DURING THE INVESTIGATION IF INDICATED. ALSO, WHEN POSSIBLE, IMMUCOR USES REMOTE ACCESS TO REVIEW THE RELEVANT DATA ARCHIVED ON THE INSTRUMENT. THE EVENTS REPORTED ON THIS QUARTERLY MALFUNCTION SUMMARY REPORT ARE LIMITED TO THOSE IN WHICH NO PATIENT HARM OCCURRED, AND NO DESIGN DEFECT (OR OTHER SYSTEMIC PROBLEM) WAS IDENTIFIED. THERE IS NO SPECIFIC ACTION THAT USERS ARE EXPECTED TO TAKE TO MITIGATE THE REPORTED DEVICE FAILURE/MALFUNCTION OTHER THAN TO ENSURE THAT PREVENTATIVE MAINTENANCE IS PERFORMED AS INDICATED IN THE INSTRUMENT INSTRUCTIONS. IMMUCOR WILL CONTINUE TO TRACK AND TREND PERFORMANCE AND OPERATIONAL ISSUES SUCH AS DESCRIBED IN THIS QUARTERLY MALFUNCTION SUMMARY REPORT.

    Description of Event or Problem · 0

    A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR ONE TEST EVENTS USING THE CAPTURE-CMV, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879186 CAPTURE-CMV TEST, DONOR, CMV MZE IMMUCOR, INC. 10888234002154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown