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 missing low alarms.The reported issue was investigated and attempted to be replicated.Per the abbott diabetes care compatibility guide for the freestyle librelink app, the reported configuration of samsung sm-a336b is not compatible with the freestyle librelink app.There were no issue identified with the freestyle librelink app during replication that would have led to the reported issue.Therefore, this issue is not confirmed.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 alarm issue was reported with the adc device in use with samsung sm-a336b with android operating system version 12.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, customer was not alerted of changes in glucose level and experienced a loss of consciousness, dizziness unable to speak, and unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered intravenous glucose for treatment.There was no report of death or permanent impairment associated with this event.
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