MalfunctionCGL
NOVA STAT PROFILE CRITICAL CARE XPRESS
Received Jul 17, 2018 · Event occurred Apr 26, 2018
Report 1219029-2018-00001 · MDR key 7694958
Device
Generic name
Clinical Chemistry Creatinine Test System
Manufacturer
Nova Biomedical CorporationModel number
35942Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
PATIENT'S PROCEDURE WAS DELAYED FOR HYDRATION THERAPY BASED ON THE CREATININE RESULT OF 1.7. NOVA BIOMEDICAL OPENED AN INTERNAL INVESTIGATION INTO THE INCIDENT.
Description of Event or Problem
PT SCHEDULED FOR R&L HEART CATH POC CREATININE RAN IN UNIT AND RESULTED AT 1.7, PROCEDURE DELAYED FOR HYDRATION THERAPY.