NBM-200

Additional Manufacturer Narrative

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

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.