NBM-200

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.