NOVA STAT PROFILE PRIME PLUS
Received Feb 23, 2022 · Event occurred Jan 24, 2022
Report 1219029-2022-00010 · MDR key 13587092
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Model number
PRIME PLUSCatalog number
57400
Product problems
- Low Test Results
- Low Test Results
Patient
61 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE NOVA PRIME PLUS ANALYZER SN (B)(4) RETURNED A LOWER CREATININE RESULT THAN A REFERENCE ANALYZER. THE PATIENT WAS GIVEN CONTRAST BASED OFF OF THIS RESULT FOR A CT SCAN.
Additional Manufacturer Narrative
THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4, G1, G4, G6, H2, H4, H5, H6, H10 CORRECTED INFORMATION: D2 UDI:(B)(4) THE USER REPORTED AN INCIDENT WITH DISCPREANT PATIENT RESULTS WHEN COMPARED TO A REFERENCE ANALYZER WHILE MEASURING CREATININE WITH A STATPROFILE PRIME PLUS ANALYZER, SERIAL NUMBER (B)(6) . THIS OCCURRED ON (B)(6) 2022. THE ANALYZER DID NOT INDICATE THERE WAS A PROBLEM WITH THE SAMPLE IN ANYWAY BEFORE PRODUCING THE RESULTS, AND THE PATIENT RECEIVED CT CONTRAST PRIOR TO THE REFERENCE ANALYZER PRODUCING A DISCREPANT RESULT. THE ANALYZER AND SENSORS WERE NOT RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. THE MANUFACTURER RETAINS OF THE SENSOR USED BY THE CUSTOMER WERE UNAVAILABLE, BUT RETAINS OF A SIMILAR LOT WHICH WAS PRODUCED THE SAME DAY WITH SAME MATERIALS AS THE SENSOR IN QUESTION WERE AVAILABLE AND TESTED. THE SENSOR PRODUCED ACCEPTABLE VALUES FOR QUALITY CONTROL TESTS, AND PRECISION TESTS WITH WHOLE BLOOD SAMPLES WERE WITHIN SPECIFICATION. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE ANALYZER AND THE CONSUMABLES IN USE AT THE TIME OF THE EVENT BY A QUALITY CONTROL ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE ANALYZER AND CONSUMABLES. NO ABNORMALITIES OR CONCERNS WERE NOTED, AND THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE CONCLUSION OF THE INVESTIGATION IS THE REPORTED CUSTOMER COMPLAINT COULD NOT BE REPRODUCED USING MANUFACTURER RETAINS OF A SIMILAR LOT OF SENSOR CARD USED BY THE CUSTOMER. A ROOT CAUSE WAS UNABLE TO BE IDENTIFIED, AND NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.