An alarm issue was reported with the adc device in use with xiaomi redmi note 12 with android 12 operating system.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced a loss of consciousness and was unable to self-treat, requiring treatment of a glucagon pen injection by a healthcare professional 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 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 device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.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 customer reported signal loss.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 xiaomi redmi note 12 pro device 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.All pertinent information available to abbott diabetes care has been submitted.
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