STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Description of Event or Problem

THE CUSTOMER REPORTED THAT OPERATOR IDS ARE NOT MATCHING WHAT IS IN THEIR HOSPITAL SYSTEM. THIS CAUSED RESULTS TO GET STUCK IN THE MIDDLEWARE AND WAS NOT BEING POSTED OVER TO EPIC.

Additional Manufacturer Narrative

ON (B)(6) 2026, THE USER INITALLY REPORTED RESULTS BENG STUCK IN THE MIDDLEWARE AND NOT TRANSMITING RESULTS TO HOSPITAL SOFTWARE. THE USER HAD REQUESTED A DOWNGRADE OF THE FIRMWARE. ADDITIONAL INFORMATION TO DETERMINE REPORTABILITY WAS RECIEVED FROM THE USER ON (B)(6) 2026, WHICH INDICATED DELAYS IN TREATEMENT DUE TO THE RESULTS NOT BEING SENT. THE METER SERIAL NUMBER WAS NOT IDENTIFIED BY THE USER. THIS COMPLAINT IS CURRENTLY BEING INVESTIGATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CONSUMER REPORTED DELAYS IN RESULTS BEING TRANSMITTED TO EPIC. DUE TO DOWNTOWN, THE CUSTOMER REPORTED THAT THE ED HAD TO RELY ON EMS STAFF GLUCOSE MONITORING WITH A COMMERICAL METER AS AN ALTERNATIVE. THIS INDICATED DELAYS IN TREATEMENT FOR PATIENTS.

Additional Manufacturer Narrative

THE CONSUMER REPORTED THIS ISSUE OCCURRED ON MULTIPLE METERS, SO DHR REVIEWS WERE UNABLE TO BE COMPLETED AS A SPECIFIC SERIAL NUMBER WAS NOT PROVIDED. NIR 6047 WAS INITIATED BY NOVA BIOMEDICAL TO FURTHER INVESTIGATE THIS ISSUE. THE ISSUE WAS CONFIRMED TO BE A POTENTIAL LOGIC ERROR THAT COULD FAIL TO SET THE ARCHIVE FLAG ON A SAMPLE AFTER IT WAS TRANSMITTED, CAUSING THE ISSUE OF REPEATED TRANSMISSIONS OF THE SAME SAMPLE. ADDITIONAL VALIDATION CHECKS HAVE BEEN INTRODUTED TO ENSURE ARCHIVED STATES ARE CONSISTENTLY APPLIED TO THE RESULTS AND A NEW SAFEGUARD PREVENTS DUPLICATE MESSAGES. IT IS ADVISED BY THE TEAM THAT METERS SHOULD BE UPGRADED TO THE V1.3.14.13 SOFTWARE. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.