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: 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 SALES REPRESENTATIVE STATED THAT THE SENSICA DEVICE WAS NOT MEASURING FLUIDS PROPERLY.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS UNCONFIRMED. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. REPORTED ISSUE COULD NOT BE REPRODUCED AS THE LOAD CELL PASSED CALIBRATION WITH NO REPLACEMENT NEEDED. SENSICA URINE OUTPUT SYSTEM WAS EVALUATED UPON RECEIPT. DURING THE EVALUATION IT WAS FOUND THAT THE REPORTED ISSUE COULD NOT BE CONFIRMED. DEVICES LOAD CELL WAS RECALIBRATED DURING SERVICE, AND THE DEVICE WAS ABLE TO SUCCESSFULLY PASS ALL FUNCTIONAL TESTING REQUIREMENTS. TESTING WAS PERFORMED IN ACCORDANCE. 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. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE SALES REPRESENTATIVE STATED THAT THE SENSICA DEVICE WAS NOT MEASURING FLUIDS PROPERLY.