MalfunctionCGL
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
Received Oct 30, 2018 · Event occurred Oct 10, 2018
Report 1219029-2018-00004 · MDR key 8021303
Device
Generic name
Electrode, Ion Based, Enzymatic, Creatinine
Manufacturer
Nova Biomedical CorporationModel number
43370Lot number
4918129129
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CURRENTLY IN PROCESS. NO PATIENT ADVERSE EVENT RESULTED FROM THE ADMINSTRATION OF CONTRAST DURING CT.
Description of Event or Problem
DISCREPANT CREATININE RESULTS ON NOVA STAT SENSOR RESULTED IN ADMINSTRATION OF CONTRAST DURING CT.