BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBM-200

    MDR report key: 24600352 · Received March 14, 2026

    Report

    Report Number
    3007358963-2026-00001
    Event Type
    Malfunction
    Date Received
    March 14, 2026
    Date of Event
    November 10, 2024
    Report Date
    March 14, 2026
    Manufacturer
    ORSENSE LTD.
    Product Code
    QGU
    PMA / PMN Number
    BK190322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT, THE DEVICE RESULTS WERE INCONSISTENT WITH A LABORATORY TEST, ALTHOUGH THE TIME INTERVAL BETWEEN THE MEASUREMENTS IS UNKNOWN. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED. THE SPECIFIC DEVICE AND EVENT LOCATION WERE NOT IDENTIFIED; THEREFORE, A DIRECT INVESTIGATION COULD NOT BE CONDUCTED. BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE CONFIRMED. ORSENSE IS SUBMITTING THIS REPORT OUT OF CAUTION.

    Description of Event or Problem · 0

    THE COMPLAINT ALLEGED THAT HEMOGLOBIN VALUES MEASURED AT THE BLOOD CENTER USING THE ORSENSE DEVICE (NBM-200) IN 2024 (11.6 G/DL) AND IN 2025 (12.4 G/DL) WERE LOW COMPARED TO THE VALUE MEASURED IN THE LABORATORY (CBC) IN 2024 (14.0 G/DL) AND PREVENTED THE POTENTIAL DONOR FROM DONATING BLOOD. NO PHYSICAL HARM IS REPORTED. BLOOD HEMOGLOBIN VALUES ARE NOT CONSTANT AND MAY VARY OVER TIME, EVEN WITHIN THE SAME DAY, DUE TO PHYSIOLOGICAL CHANGES, SUCH AS VARIATIONS IN BODY HYDRATION AND IRON LEVELS. ORSENSE WAS UNABLE TO DETERMINE WHETHER THE TWO TESTS PERFORMED IN 2024 (NBM-200 AND THE LABORATORY) WERE CONDUCTED AT THE SAME TIME. THE DIFFERENCES BETWEEN THE NBM-200 MEASUREMENTS AND THE LABORATORY RESULT MAY SIMPLY REFLECT PHYSIOLOGICAL VARIATIONS OVER TIME RATHER THAN A DEVICE-RELATED ISSUE. SIMILARLY. DEVICE MEASUREMENTS ARE SENSITIVE TO PERFUSION, FINGER TEMPERATURE, MOTION AND POSITIONING. INFORMATION REGARDING THE SPECIFIC DEVICE UTILIZED FOR THE MEASUREMENTS OR THE CONDITIONS UNDER WHICH THE MEASUREMENTS WERE TAKEN WAS NOT AVAILABLE. BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661532 NBM-200 HEMOGLOBIN FOR DONOR TESTING QGU ORSENSE LTD. NBM-200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female