MalfunctionQGU
FINGER SENSOR USED BY ONEBLOOD DONATION CENTER
Received Jun 28, 2022 · Event occurred May 24, 2022
Report MW5110608 · MDR key 14856268
Device
Generic name
Hemoglobin For Donor Testing
Manufacturer
UnkProduct problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
70 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
I ATTEMPTED TO DONATE BLOOD FOR ONEBLOOD. I WAS DENIED BECAUSE THE SENSOR DETECTED THAT I WAS LOW ON IRON. THIS HAPPENED EVEN THOUGH I HAD AN ACTUAL BLOOD DRAW, AND IRON WAS TESTED BY QUEST LABORATORY ON (B)(6) 2022 AND THE LEVELS WERE WELL WITHIN ACCEPTABLE RANGE. THEREFORE, THE SENSORS THEY ARE USING ARE INVALID. ACTUAL BLOOD TEST WAS DONE ON THE ABOVE DATE (B)(6) 2022 BY QUEST DIAGNOSTICS. FDA SAFETY REPORT ID# (B)(4).