STAT STRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

INVESTIGATION ANTICIPATED, NOT YET BEGUN. PRODUCT HAS NOT BEEN RETURN AT TIME OF THIS SUBMISSION. NOVA BIOMEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THERE WAS NO REPORT OF PATIENT BEING TREATED AS A RESULT OF THE CAPILLARY FINGERSTICK RESULT OF 526MG/DL. THE DIFFERENCE BETWEEN THE REPLICANT VALUES WAS NOTED TO BE CLINICALLY SIGNIFICANT.

Description of Event or Problem

THE COMPLAINANT REPORTS UNEXPECTED ELEVATED POSTPRANDIAL GLUCOMETER RESULT. THE REPLICATE RESULTS OBTAINED WITHIN THREE MINUTES.

Additional Manufacturer Narrative

THE PATIENT IDENTIFIER WAS UPDATED FROM (B)(6) IN THE INITIAL REPORT TO (B)(6). THE DEVICE (GLUCOMETER) AND TEST STRIPS IN QUESTION WERE RETURNED FOR EVALUATION ON 12/10/2025. RETAINED AND RETURNED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325077249) WERE USED FOR THE COMPLAINT INVESTIGATION. TESTING INCLUDED FIVE (5) LEVELS OF WHOLE BLOOD SPECIMENS COLLECTED FROM CONSENTING ADULTS. FIVE (5) NOVA STATSTRIP GLUCOSE METERS WERE USED FOR THE STUDY ALONG WITH ONE (1) RETURNED NOVA STATSTRIP GLUCOSE METER (SN (B)(6). FOUR (4) MEASUREMENTS WERE PERFORMED ON EACH METER FOR EACH SAMPLE (24 MEASUREMENTS TOTAL). PLASMA YSI GLUCOSE RESULTS WERE USED AS REFERENCE VALUES FOR THE WHOLE BLOOD SPECIMENS. RETAINED AND RETURNED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325077249) MET THE PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SPECIMENS FOR TESTING DONE USING RETAINED AND ONE (1) RETURNED NOVA STATSTRIP GLUCOSE METERS. THERE WERE NO DISCREPANT VALUES OBTAINED DURING THE TESTING OF NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325077249). THE RESULTS DESCRIBED IN THE COMPLAINT COULD NOT BE REPRODUCED. A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY IDENTIFIED BASED ON THE INFORMATION PROVIDED AND THE RETAIN TESTING PERFORMED. DHR (DEVICE HISTORY RECORD) REVIEWS WERE PERFORMED ON THE REPORTED METER AND STRIP LOT. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.