NOVA STATSENSOR CREATININE HOSPITAL METER
Received Mar 22, 2012 · Event occurred Mar 12, 2012
Report 1219029-2012-00001 · MDR key 2506034
Device
Generic name
Cgl - Creatinine Test System
Manufacturer
Nova BiomedicalModel number
43370Catalog number
43370
Lot number
4911180249
Product problems
- Incorrect Or Inadequate Test Results
- Device Operates Differently Than Expected
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS DETERMINED BY THE HOSPITAL THAT A SINGLE NOVA STATSENSOR HOSPITAL METER CREATININE CAPILLARY PT RESULT WAS CLINICALLY SIGNIFICANTLY DIFFERENT THAN THE RESULT OBTAINED FROM A VENOUS SAMPLE FROM THE SAME PT ON THE HOSPITAL LABORATORY ANALYZER (SIEMEN ADVIA). PT; STATSENSOR RESULT: 0.75 MG/DL, LAB RESULT: 1.57 MG/DL. THE HOSPITAL THRESHOLD FOR THE ALLOWANCE OF THE ADMINISTRATION OF CONTRAST MEDIA IS A RESULT BELOW 1.50 MG/DL. THEREFORE THE PT WAS GIVEN CONTRAST MEDIA BASED ON THE RESULT FORM THE METER. PER THE REPORTER, THE PT WAS GIVEN IV SOLUTION TO DIFFUSE THE MEDIA AND WAS RELEASED TO GO HOME. AS OF THE DATE OF THIS REPORT, NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Additional Manufacturer Narrative
EVALUATION SUMMARY: THE INTERNAL INVESTIGATION ((B)(4)) TEST RESULTS SHOWED THAT THE RETAINS OF THE CUSTOMER CREATININE TEST STRIP LOT (LOT# 4911180249) MET THE DEFINED 510K CLEARANCE ACCEPTANCE CRITERIA FOR BOTH WHOLE BLOOD AND QUALITY CONTROL TESTING. THERE WERE NO OBVIOUS RESULT DISCREPANCIES OBSERVED AT ANY CREATININE LEVEL IN THE INVESTIGATION. IN SUMMARY, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THAT INFORMATION WAS REPORTED TO THE INITIAL REPORTER.