STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

THE METER WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE RETURNED PRODUCT A DETAILED INVESTIGATION ON THE FAILED PRODUCT COULD NOT BE PERFORMED, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. FURTHER INFORMATION PROVIDED INDICATES THE METER RAN PROPERLY DURING PATIENT TEST, BUT WHEN METER CONNECTED TO NOVA NET AND ON TO QML (MIDDLEWARE) THE PATIENT ID WAS NO LONGER VISIBLE. THIS CAUSES AN EXCEPTION IN MIDDLEWARE FORCING THE POC TO MODIFY AND ADJUST THE PATIENT ID PROPERLY BEFORE GOING ONTO THE PATIENT'S CHART. THE CUSTOMER FURTHER INDICATED THAT THIS WAS A RANDOM OCCURRENCE, IT ONLY HAPPENED ONCE ON THIS METER. THE METER REMAINED IN SERVICE AT THE FACILITY. THE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. WHEN NOVA BIOMEDICAL REQUESTED FURTHER INFORMATION ON POTENTIAL PATIENT IMPACT THE ANSWER PROVIDED WAS "UNKNOWN". A DHR REVIEW WAS PERFORMED. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Description of Event or Problem

"PATIENT ID SHOWS UP AS UNKNOWN IN QML AND ON THE METER THERE IS A BLANK SPACE FOR THAT TEST".