The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.The dhrs (device history record) for the libre reader were reviewed, and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated and no physical damage were observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The sensor was activated with a known good reader and the bluetooth connection was successful.The current was applied to the sensor to perform linearity testing while in the test fixture.Reader settings were configured through masterm.The reader was wrapped in aluminum foil to stimulate signal loss massage.Signal loss alarm/message was did not observed.An extended investigation has been performed on returned sensor.Visual inspection has been performed on the returned sensor and no issues were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Visual inspection has been performed on the returned reader and no issues were observed.Returned sensor was activated to receive ble (bluetooth) packets.Reader was connected to masterm and ble packets were received.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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