SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE DID NOT SHOW THE PREVIOUS HOUR AFTER 10 AM EVEN THOUGH, IT WAS CURRENTLY 1PM. IT SHOWED THE PREVIOUS 3 HOURS OF OUTPUT UNDER THE 10 AM HOUR.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE DID NOT SHOW THE PREVIOUS HOUR AFTER 10 AM EVEN THOUGH, IT WAS CURRENTLY 1PM. IT SHOWED THE PREVIOUS 3 HOURS OF OUTPUT UNDER THE 10 AM HOUR. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 24JUN2025, THEY REPORTED AN ISSUE WHERE THE DEVICE ONLY DISPLAYED OUTPUT UNDER THE 10:00 AM HOUR, EVEN THOUGH THE PATIENT CONTINUED PRODUCING URINE FOR THE NEXT FOUR HOURS. THE DATA GRAPH SHOWS ALL THE OUTPUT FROM THAT PERIOD GROUPED UNDER 10:00 AM, RATHER THAN BEING DISTRIBUTED ACROSS THE SUBSEQUENT HOURS. ON SCREEN THEY CAN SEE THE LAST HOUR LISTED WAS 9-10 AM, BUT THE TIME ON THE BOTTOM OF THE SCREEN WAS 2:34 PM SO THE DEVICE HAS SKIPPED MULTIPLE HOURS AND WAS COMPILING IT ALL UNDER THE 2PM HOUR. THEY WOULD TRY THE POWER CYCLE AS THEY MENTIONED, BUT THEY DO THINK THEY SHOULD SEE IF THEY CAN PULL THE LOGS TO GET THIS INVESTIGATED FURTHER ¿ ESPECIALLY IF THIS WAS NOT THE FIRST TIME, THEY HAVE SEEN IT. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 02JUL2025, SPOKE WITH THEM AND IT WAS REPORTED THEY WERE UNABLE TO PROVIDE THEM ANY ASSISTANCE DURING THE TECHNICAL SUPPORT CALL. THE SCREEN CONTINUED TO NOT DISPLAY THE CORRECT INFORMATION. THEY WERE OFF WORK AFTER THAT AND WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. PER REVIEW OF WORK ORDER ON 08JAN2026, THE FLOOR WAS NOTIFIED TO SEND THIS DEVICE DOWN TO BIOMED SO THAT BIOMED CAN OBTAIN DATA LOGS. BIOMED STATED THAT THE DEVICE DID NOT SHOW THE PREVIOUS HOUR AFTER 10 AM EVEN THOUGH IT WAS CURRENTLY 1PM. IT SHOWED THE PREVIOUS 3 HOURS OF OUTPUT UNDER THE 10 AM HOUR. DEVICE WAS POWER CYCLED, AND THE DEVICE BEGAN RECORDING THE OUTPUT AS NORMAL.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE FOR THE REPORTED EVENT WAS NOT ABLE TO BE DETERMINED. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 24JUN2025, THEY REPORTED AN ISSUE WHERE THE DEVICE ONLY DISPLAYED OUTPUT UNDER THE 10:00 AM HOUR, EVEN THOUGH THE PATIENT CONTINUED PRODUCING URINE FOR THE NEXT FOUR HOURS. THE DATA GRAPH SHOWS ALL THE OUTPUT FROM THAT PERIOD GROUPED UNDER 10:00 AM, RATHER THAN BEING DISTRIBUTED ACROSS THE SUBSEQUENT HOURS. ON SCREEN THEY CAN SEE THE LAST HOUR LISTED WAS 9-10AM, BUT THE TIME ON THE BOTTOM OF THE SCREEN WAS 2:34 PM SO THE DEVICE HAS SKIPPED MULTIPLE HOURS AND WAS COMPILING IT ALL UNDER THE 2:00 PM HOUR. PER TECHNICAL SUPPORT NOTES IN WO, THE FLOOR WAS NOTIFIED TO SEND THE DEVICE TO BIOMED SO THAT BIOMED CAN OBTAIN DATA LOGS, DEVICE WAS POWER CYCLED, AND THE DEVICE BEGAN RECORDING THE OUTPUT AS NORMAL. PER FOLLOW UP INFORMATION RECEIVED, IT WAS REPORTED THEY WERE UNABLE TO PROVIDE THEM ANY ASSISTANCE DURING THE TECHNICAL SUPPORT CALL. THE SCREEN CONTINUED TO NOT DISPLAY THE CORRECT INFORMATION. REVIEW OF THE DHR DID NOT INDICATE ANY MANUFACTURING NONCONFORMANCE THAT COULD HAVE CAUSED AND/OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS-FOR-USE ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.