SENSICAUOMONITOREVAL

Additional Manufacturer Narrative

UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS VERY INCONSISTENT IN ITS RESPONSE TO TOUCH. IT HAD TOUCHSCREEN ISSUES. PER INFORMATION RECEIVED FROM CUSTOMER ON 17APRIL23, UNIT WAS IN BD CONTROL AND WAS MARKED AS EVALUATION UNIT AND ISSUE WAS FOUND DURING TESTING AND WAS NOT USED ON HUMAN TRIAL.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS VERY INCONSISTENT IN ITS RESPONSE TO TOUCH. IT HAD TOUCHSCREEN ISSUES. PER INFORMATION RECEIVED FROM CUSTOMER ON 17APRIL23, UNIT WAS IN BD CONTROL AND WAS MARKED AS EVALUATION UNIT AND ISSUE WAS FOUND DURING TESTING AND WAS NOT USED ON HUMAN TRIAL.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.