An error message was reported with the adc device in use with an iphone 12 phone with ios 17 operating system.Customer received a "start new sensor" message and was unable to obtain readings.As a result, customer experienced "0 level of motor skills and extreme levels of confusion" and a loss of consciousness and was unable to self-treat, requiring healthcare provider administration of iv glucose for treatment of a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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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.The customer¿s product has been requested for investigation.At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.The customer reported event code 365 with freestyle libre 2 app.Adc attempted to replicate the reported issue using similar configuration of [iphone 13 mini, ios 17.0.3, 2.7.5.4061].The reported issue was unable to be replicated and the system functioned as intended.There were no issue identified with the fs libre 2 app during replication that would have led to the reported issue.Therefore, this issue is not confirmed.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.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 was observed on the 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, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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An error message was reported with the adc device in use with an iphone 12 phone with ios 17.1.2 operating system and app version 2.7.5.4061.Customer received a "start new sensor" message and was unable to obtain readings.As a result, customer experienced "0 level of motor skills and extreme levels of confusion" and a loss of consciousness and was unable to self-treat, requiring healthcare provider administration of iv glucose for treatment of a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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