BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBM-200

    MDR report key: 24600354 · Received March 14, 2026

    Report

    Report Number
    3007358963-2026-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2026
    Date of Event
    May 31, 2025
    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

    THE COMPLAINT LACKED SUFFICIENT INFORMATION, AND THE SPECIFIC DEVICE WAS NOT IDENTIFIED, THEREFORE, A COMPREHENSIVE INVESTIGATION COULD NOT BE CONDUCTED. MEASUREMENT VARIABILITY MAY OCCUR DUE TO PHYSIOLOGICAL CONDITIONS, SUCH AS REDUCED PERIPHERAL PERFUSION WITH COLD EXTREMITIES. BASED ON THE AVAILABLE INFORMATION, NEITHER A SERIOUS INJURY NOR A DEVICE MALFUNCTION WERE CONFIRMED. OR SENSE IS SUBMITTING THIS REPORT OUT OF CAUTION.

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGED COLD-LIKE SYMPTOMS (FEVER, CHILLS AND BODY ACHES) FOLLOWING A BLOOD DONATION. ACCORDING TO THE COMPLAINT, THE BLOOD DONOR'S HEMOGLOBIN LEVEL WAS INITIALLY MEASURED AS BELOW AVERAGE, WHICH ROSE TO A DONATION-ELIGIBLE LEVEL UPON A SECOND MEASUREMENT AFTER THE DONOR WAS GIVEN A HAND WARMING PACKET. THE COMPLAINANT BELIEVES THE INITIAL READING WAS THE TRUE HEMOGLOBIN LEVEL. THE REPORTED EVENT MAY REFLECT NON-DEVICE RELATED CONDITIONS AND/OR A USER ERROR. AS STATED IN THE NBM-200 USER GUIDE, MEASUREMENT BY THE DEVICE IS SENSITIVE TO PERFUSION, FINGER TEMPERATURE, MOTION AND POSITIONING, AND A COLD FINGER MAY ADVERSELY AFFECT MONITOR READINGS. ACCORDINGLY, THE OPERATOR SHOULD ENSURE THAT THE SUBJECT'S HAND IS WARM AND THAT BLOOD FLOWS THROUGH THE FINGERS WITHOUT INTERRUPTION. IF THE HAND FEELS COLD, THE PATIENT IS ASKED TO WARM THE HAND BEFORE TESTING. BASED ON THE AVAILABLE INFORMATION AND AFTER CONSULTING WITH A MEDICAL PROFESSIONAL, THERE IS NO BASIS TO ASSUME THAT THE DONOR'S SYMPTOMS WERE ASSOCIATED WITH ACUTE ANEMIA DUE TO BLOOD DONATION. ACCORDINGLY, NEITHER A DEVICE MALFUNCTION NOR A SERIOUS INJURY WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661525 NBM-200 HEMOGLOBIN FOR DONOR TESTING QGU ORSENSE LTD. NBM-200

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Unknown