MalfunctionCGL
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
Received Dec 11, 2018 · Event occurred Nov 11, 2018
Report 1219029-2018-00009 · MDR key 8151907
Device
Generic name
Electrode, Ion Based, Enzymatic, Creatinine
Manufacturer
Nova Biomedical CorporationModel number
43370Lot number
4918192129
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
NO ADVERSE EVENT REPORTED, INVESTIGATION ONGOING.
Description of Event or Problem
DISCREPANT CREATININE RESULTS USING NOVA STAT SENSOR COMPARED TO LAB REFERENCE. PATIENT RECEIVED WRONG CONTRAST AS A RESULT.