STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

INVESTIGATION IS CURRENTLY IN PROCESS. THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECT OR TREATMENT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

METER WAS FOUND TO HAVE SENT INCORRECT PATIENT RESULTS ON (B)(6). THE METER SHOWS A RESULT OF 75MG/DL BUT THE RESULT SENT TO THE PATIENT CHART WAS 350MG/DL.

Additional Manufacturer Narrative

THE ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE BUG WITHIN THE GEN 2 STATSTRIP HOSPITAL METER FIRMWARE RESULTING IN TWO QUERIES ACCESSING THE DATABASE (DB) AT THE SAME TIME TO RETRIEVE A TEST RESULT RECORD. THIS RESULTED IN AN ADDITIONAL RANDOM TEST RESULT RECORD BEING RETRIEVED IN ADDITION TO THE ORIGINAL TEST RESULT RECORD. UNDER THIS CONDITION, THE POTENTIAL EXISTED FOR TWO GLUCOSE TEST RESULT RECORDS TO BE TRANSMITTED TO A HEALTHCARE SYSTEM'S DATA MANAGEMENT SYSTEM. TO PREVENT THE POSSIBILITY OF OCCURRENCE, NOVA BIOMEDICAL ADDED LOCKS WITHIN THE DB TO ENSURE THAT TWO QUERIES CANNOT ACCESS THE TEST RESULT RECORDS CONTAINED WITHIN THE DB. THE ROOT CAUSE WAS DETERMINED TO A SOFTWARE BUG IN THAT TWO QUERIES WERE ACCESSING THE DATABASE (DB) AT THE SAME TIME TO RETRIEVE A TEST RESULT RECORD. NOVA BIOMEDICAL HAS INITIATED AN URGENT FIELD SAFETY CORRECTION. THE POTENTIAL SOFTWARE RISK DESCRIBED IN THIS NOTIFICATION HAS BEEN CORRECTED AND VALIDATED THROUGH THE RELEASE OF A NEW SOFTWARE VERSION (V0.0.13.45 AND ABOVE) FOR THE STATSTRIP GLUCOSE AND GLUCOSE/KETONE HOSPITAL METER SYSTEMS. THE NEW SOFTWARE RELEASE ELIMINATES THE POTENTIAL RISK OF TRANSMITTING ERRONEOUS GLUCOSE PATIENT TEST RESULTS TO A HEALTHCARE SYSTEM'S DATA MANAGEMENT SYSTEM. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS