STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

PER FDA REQUEST, PRODUCT CODE WAS ADJUSTED ACCORDINGLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT WITH A DEATH OF A PATIENT IN RESPIRATORY FAILURE WERE MADE ON MAY 21ST AND MAY 28TH, 2026. THERE WAS NO RESPONSE FROM THE INITIAL REPORTER AND ADDITIONAL INFORMATION REGARDING TIMELINE OF EVENTS ARE UNAVAILABLE. IT WAS NOTED IN THE INITIAL REPORT THAT THE SAME METER AND TEST STRIPS WERE USED ON PATIENTS AFTER THE EVENT AND RESULTS WERE COMPARABLE TO THE LAB ANALYZER BEING USED. REQUESTS FOR RESULTS OF THE METER BEING USED AND THE LAB ANALYZER WERE REQUESTED BY THE TECHNICAL SUPPORT TEAM BUT WERE NOT PROVIDED. THE METER AND TEST STRIPS WERE NOT RETURNED TO NOVA BIOMEDICAL FOR FURTHER EVALUATION. RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT NUMBER 0325324249) WERE USED TO INVESTIGATE THE COMPLAINT. TESTING INCLUDED SAMPLES OF LINEARITY SOLUTION AND WHOLE BLOOD SPECIMENS COLLECTED FROM CONSENTING ADULTS. SAMPLES WERE RUN ON RETAINED NOVA STATSTRIP GLUCOSE METERS. THE RETAINED TEST STRIPS MET PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SPECIMENS. THE DISCREPANT RESULTS DESCRIBED BY THE INITIAL REPORTER WERE NOT REPRODUCED DURING TESTING. ALL DEVICE HISTORY RECORDS INDICATED THAT THE RELEASED PRODUCTS MET ALL SPECIFICATIONS. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Additional Manufacturer Narrative

A DHR REVIEW WAS PERFORMED FOR THE REPORTED METER AND TEST STRIP LOTS. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE INITAL REPORTER NOTED THAT OTHER PATIENTS TESTED WITH THIS METER AND LOT NUMBER OF TEST STRIPS SHOWED RESULTS COMPARABLE TO THE LAB ANALYZER RESULTS ON THE SAME DAY. QC RESULTS WERE REPORTED AND WITHIN RANGE PRIOR TO TESTING. ADDITIONAL INFORMATION FROM THE INITIAL REPORTER REGARDING OTHER COMORBIDITIES OF THE PATIENT HAS NOT BEEN PROVIDED AT THE TIME OF THIS REPORT. THIS IS BEING FURTHER INVESTIGATED BY NOVA BIOMEDICAL AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

Description of Event or Problem

RESULTS ON A PATIENT DO NOT MATCH MAIN ANALYZER. PATIENT ARRIVED AT (B)(6) EMERGENCY DEPARTMENT WITH ACUTE RESPIRATORY FAILURE. PATIENT PASSED AWAY.