NOVA STATSENSOR CREATININE HOSPITAL METER
Received Jul 12, 2012 · Event occurred Jul 12, 2011
Report 1219029-2012-00008 · MDR key 2659556
Device
Generic name
Cgl - Creatinine Test System
Manufacturer
Nova BiomedicalModel number
44052Lot number
47055010286
Product problems
- Incorrect Or Inadequate Test Results
Patient
UNKNOWN
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
REPORTED THAT NOVA STATSENSOR HOSPITAL METER CREATININE PT RESULT WAS CLINICALLY SIGNIFICANTLY DIFFERENT THAN THE RESULT OBTAINED FROM A VENOUS SAMPLE FROM THE SAME PT ON THE HOSPITAL LABORATORY ANALYZER (ROCHE CHEMISTRY ANALYZER). PATIENT: STATSENSOR RESULT: 1.14 MG/DL; LAB RESULT: 1.84 MG/DL. THE HOSPITAL THRESHOLD FOR THE ALLOWANCE OF THE ADMINISTRATION OF CONTRAST MEDIA IS A RESULT BELOW 1.50 MG/DL. THE PT WAS GIVEN CONTRAST MEDIA BASED ON THE RESULT FROM THE METER. AS OF THE DATE OF THIS REPORT, NO ADVERSE EFFECTS HAVE BEEN REPORTED TO THE MANUFACTURER.
Additional Manufacturer Narrative
REPORTER COMMUNICATED EVENT TO MANUFACTURER 11 MONTHS AFTER OCCURRENCE. MANUFACTURER AND REPORTER CANNOT DETERMINE LOT NUMBER OF TEST STRIPS IN USE AT TIME OF EVENT ((B)(6) 2011). REPORTER FORWARDED TO MANUFACTURER A VIAL OF TEST STRIPS CURRENTLY IN USE (B)(4) THAT WERE MANUFACTURED IN (B)(4) 2012. THE MANUFACTURER PERFORMED AN INTERNAL INVESTIGATION ((B)(4)). THE RETURNED TEST STRIPS FROM THE REPORTER AND THE MANUFACTURER RETAINS MET THE DEFINED 510K CLEARANCE ACCEPTANCE CRITERIA FOR BOTH WHOLE BLOOD AND QUALITY CONTROL TESTING.