MalfunctionCGL
STAT PROFILE PRIME PLUS ANALYZER SYSTEM
Received Nov 19, 2019 · Event occurred Nov 4, 2019
Report 1219029-2019-00072 · MDR key 9344974
Device
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A NOVA BIOMEDICAL FIELD SERVICE TECHNICIAN VISITED THE USER FACILITY TO SERVICE THE ANALYZER. THEY DETERMINED THAT THE ISSUE WAS CAUSED BY A CALIBRATOR CARTRIDGE THAT WAS NOT PROPERLY PREPARED PRIOR TO USE. THE FIELD SERVICE TECHNICIAN CONFIRMED THAT REPLACING THE CALIBRATOR CARTRIDGE RESOLVED THE ISSUE AND RETURNED THE ANALYZER TO SERVICE.
Description of Event or Problem
A USER FACILITY REPORTED A NOVA BIOMEDICAL PRIME PLUS ANALYZER THAT SHOWED DISCREPANT CREATININE RESULTS WHEN COMPARED TO THEIR REFERENCE ANALYZER. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED.