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 BD CLINICAL MANAGER CALLED AND STATED THAT THE SENSICA DEVICES HOUR DISPLAY WAS FROZEN ON THE PREVIOUS 3 HOURS AND DID NOT UPDATE TO REFLECT THE CURRENT HOUR. THE ML WAS STILL READING CORRECTLY AND ACCURATELY BUT THE HOUR DISPLAY WAS FROZEN.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS UNCONFIRMED. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REPORTED ISSUE COULD NOT BE REPRODUCED AS THE TIME WAS DISPLAYED CORRECTLY THROUGHOUT THE ENTIRETY OF THE TESTING. THE SENSICA URINE OUTPUT SYSTEM WAS EVALUATED UPON RECEIPT. (SENSICA) NO ERROR CODE OBSERVED. DEVICES PCB WAS REFLASHED, TIME WAS DISPLAYED CORRECTLY THROUGHOUT THE ENTIRETY OF TESTING. TESTING WAS PERFORMED IN ACCORDANCE WITH (B)(4). DEVICE PASSED ALL APPLICABLE TESTING. DHR, RISK, AND LABELING REVIEWS ARE NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D, F, H. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE BD CLINICAL MANAGER CALLED AND STATED THAT THE SENSICA DEVICES HOUR DISPLAY WAS FROZEN ON THE PREVIOUS 3 HOURS AND DID NOT UPDATE TO REFLECT THE CURRENT HOUR. THE ML WAS STILL READING CORRECTLY AND ACCURATELY BUT THE HOUR DISPLAY WAS FROZEN. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 02JUL2025, THE UNIT WILL BE SENT IN FOR EVALUATION. CUSTOMER SERVICE HAS PROVIDED A RETURN SHIPPING LABEL. WANTED TO CONFIRM THE BEST LOCATION FOR ITS RETURN. THE ISSUE WAS RESOLVED BY POWERING OFF THE DEVICE, WAITING 10 SECONDS, AND RESTARTING IT. UPON RESTART, THE TIME AND HOUR WERE CORRECT, AND URINE OUTPUT MONITORING RESUMED. HOWEVER, PREVIOUS DATA DID NOT DISPLAY, DESPITE USING THE SAME RING AND PATIENT ID. THE PATIENT COMPLETED THERAPY ON THE DEVICE. THERE WAS NO IMPACT TO THE PATIENT. THE ONLY EFFECT WAS ON NURSING WORKFLOW, AS HOURLY OUTPUT FROM 5 AM TO 10 AM WAS UNAVAILABLE. THE RN HAD TO MANUALLY EMPTY THE COLLECTION SYSTEM AND AVERAGE THE OUTPUT FOR THOSE HOURS.