MalfunctionCGL
NOVA STAT PROFILE PHOX ULTRA
Received Jan 11, 2019 · Event occurred Sep 17, 2018
Report 1219029-2019-00001 · MDR key 8241317
Device
Generic name
Electrode, Ion Based, Enzymatic, Creatinine
Manufacturer
Nova Biomedical CorporationModel number
42014Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
NO ADVERSE EVENT OR PATIENT IMPACT WAS REPORTED. INVESTIGATION ONGOING.
Description of Event or Problem
(B)(6) 2018: DISCREPANT CREATININE RESULTS FOR PATIENT IN CANCER CENTER WHEN COMPARED TO LAB.