FDA Adverse Event Injury Summary report: N

ORSENSE

MDR report key: 22188173 · Received June 11, 2025

Report

Report Number
MW5171349
Event Type
Injury
Date Received
June 11, 2025
Date of Event
May 31, 2025
Report Date
June 2, 2025
Manufacturer
ORSENSE LTD
Product Code
QGU
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY NAME IS (B)(6) AND I DONATED BLOOD THIS PAST SATURDAY AT APPROXIMATELY 4PM ON THE ONEBLOOD BUS THAT WAS STATIONED AT (B)(6). I AM NOW EXPERIENCING COLD-LIKE SYMPTOMS, SUCH AS A FEVER, CHILLS, AND BODY ACHES. PLEASE ALLOW ME TO ELABORATE ON MY EXPERIENCE. WHEN MY VITALS WERE TAKEN USING AN ORSENSE MACHINE, I WAS TOLD THAT I HAD A HEMOGLOBIN LEVEL OF 9G/DL, WHICH IS WELL BELOW THE NORMAL RANGE FOR A MALE. I WAS THEN GIVEN A HAND WARMING PACKET BY THE PHLEBOTOMIST AND WAS TOLD TO HOLD ONTO IT FOR A FEW MINUTES SO THAT SHE COULD RETEST ME. SEVERAL MINUTES LATER, MY HEMOGLOBIN LEVEL ROSE TO 16.7G/DL, SUPPOSEDLY MAKING ME ELIGIBLE FOR DONATION. EVIDENTLY, IT IS FACTUALLY INACCURATE THAT HAND WARMERS INCREASE HEMOGLOBIN LEVELS IN THE BLOOD. I DID NOT KNOW THAT PRIOR TO MY DONATION. ADDITIONALLY, THE PHLEBOTOMIST DID NOT WRITE HER NAME ON THE DONOR INSTRUCTIONS PAPER THAT SHE HANDED ME TOWARD THE END OF MY DONATION. I DO NOT RECALL HER WEARING A NAME TAG EITHER. I HAVE DONATED WITH ONEBLOOD SEVERAL TIMES IN THE PAST AND HAVE NEVER ENCOUNTERED THESE ISSUES BEFORE. I UNDERSTAND THAT BLOOD IS IN HIGH DEMAND RIGHT NOW, BUT NEGLECTING THE HEALTH OF DONORS TO MEET A QUOTA IS HIGHLY UNETHICAL FOR BOTH DONORS AND RECIPIENTS. I AM REACHING OUT HERE BECAUSE ONEBLOOD HAS NEGLECTED TO HAVE A MEDICAL PROFESSIONAL CALL ME CONCERNING THE INCIDENT. THE PHLEBOTOMIST USED AN ORSENSE MACHINE TO MEASURE MY HEMOGLOBIN. THE FIRST READING WAS 9G/DL AND THE SECOND WAS 16.7G/DL AFTER HOLDING A HAND WARMING PACKET FOR 5 MINUTES. I AM NOW ILL AND BELIEVE THAT THE FIRST READING WAS MY TRUE HEMOGLOBIN LEVEL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
814889 ORSENSE HEMOGLOBIN FOR DONOR TESTING QGU ORSENSE LTD

Patients

Seq Age Sex Outcome Treatment
1 28 YR Unknown