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 reported a missing high/glucose alarms with the freestyle librelink application.Abbott diabetes care attempted to replicate the reported issue and the reported configuration of the device and android 14 is not compatible with the freestyle librelink application.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 therefore not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported an alarm issue with the adc device in use with a google pixel 7 phone with android version 14.The customer indicated that the high/low glucose alarm did not sound and was therefore not made aware of changing glucose levels.The customer experienced tiredness, seizure, and loss of consciousness, requiring treatment of intravenous glucose.There was no report of death or permanent impairment associated with this event.
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