DAXOR
Received Mar 16, 2026 · Event occurred Mar 6, 2026
Report MW5185344 · MDR key 24618549
Device
Generic name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medic
Manufacturer
Daxor CorporationModel number
3094D1J2W12ACatalog number
BVA-100
Patient
70 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EXCEPTIONALLY ELEVATED NORMALIZED HEMATOCRIT RESULT SENT TO PRESCRIBER. THIS RESULT WAS NOT ACKNOWLEDGED AS ABERRANT DESPITE BEING CLINICALLY IMPOSSIBLE. IF CLINICAL ACTIONS WERE TAKEN BASED ON THIS REPORTED RESULT, PATIENT INJURY COULD HAVE OCCURRED. OTHER ERRANT RESULTS WERE REPORTED BY THIS FACILITY- (B)(6), ON THE SAME DATE OF SERVICE BRINGING INTO QUESTION ANY RESULTS WITHIN NORMAL LIMITS OR THAT DID NOT SKEW TO CREATE AN ALERT. THERE IS NO COMPARABLE TEST AVAILABLE TO CLINICALLY CORRELATE TEST RESULTS.