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.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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A customer reported an unspecified sensor-related error message with the adc device and was unable to obtain readings.As a result, the customer experienced symptoms of feeling very cold, seizure, and a loss of consciousness.The customer presented at the hospital and had contact with a healthcare professional who provided glucagon for treatment.There was no report of death or permanent injury associated with this event.
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned applicator; no issues were observed.The applicator has been fired correctly.The sensor plug was properly seated and no physical damage is observed on sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.Section d4 (serial number) was updated from (b)(6).All pertinent information available to abbott diabetes care has been submitted.
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A customer reported an unspecified sensor-related error message with the adc device and was unable to obtain readings.As a result, the customer experienced symptoms of feeling very cold, seizure, and a loss of consciousness.The customer presented at the hospital and had contact with a healthcare professional who provided glucagon for treatment.There was no report of death or permanent injury associated with this event.
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