An unspecified issue was reported with the adc device in use with iphone 2020 se with ios operating system version 17.1.2.The customer was unable to obtain a sensor scan reading due to an incompatible operating system issue.As a result, the customer was unable to monitor glucose with sensor readings and experienced a loss of consciousness, ¿can¿t think¿, and sweating.The customer was able to self-treat with jelly babies and soft drinks.No additional information was provided.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 software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.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.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported app issues.Adc attempted to replicate the reported issue using similar configuration of iphone se, ios 17.1.2, 2.10.2.7677.The reported configuration of ios 17.1.2 is not compatible with the freestyle librelink app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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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