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.The customer¿s product data has been requested for investigation.A follow-up report will be filed once additional information is obtained.Per smartphone compatibility information, with use of application, the customer's device (phone) has not been tested for compatibility at the time of investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.This guide is available to the user on the websites where the product is launched.Therefore, this issue is not confirmed.The customer reported that the freestyle librelink app has been crashing due to incompatible os.The reported issue was investigated per (b)(4) revision b and attempted to be replicated.Per the abbott diabetes care compatibility guide for the freestyle librelink app art39109-001, the reported configuration of ios 16.7.5 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 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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An unspecified issue was reported with the adc device in use with iphone 8 phone with ios 16 operating system.Customer was unable to access their freestyle librelink app due to the app continually crashing.As a result, the customer was unable to monitor glucose with sensor readings and experienced confusion and a loss of consciousness, requiring treatment of glucose drinks by a healthcare provider for treatment of a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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