NOVA STATSENSOR CREATININE HOSPITAL METER

Description of Event or Problem

REPORTED 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. LAB ANALYZER (SIEMEN ADVIA). PT, STATSENSOR RESULT: 1.34 MG/DL, LAB RESULT: 1.80 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 FROM 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

EVAL SUMMARY: THE INTERNAL INVESTIGATION ((B)(4)) TEST RESULTS SHOWED THAT RETURNED TEST STRIPS FROM THE REPORTER AND THE MFR RETAINS OF THE REPORTER CREATININE TEST STRIP LOT (LOT# 4911265249) 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 INFO WAS REPORTED TO THE INITIAL REPORTER.