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 experienced missing high/low glucose alarms with freestyle libre 3 application.Adc attempted to replicate the reported issue using similar configuration of samsung galaxy s9 with android 10 for freestyle libre 3 app version 3.5.1.10363.The reported issue was unable to be replicated and the system functioned as intended.There was no issue identified with the freestyle libre 3 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 unspecified issue was reported with the adc device in use with a samsung galaxy note 9 phone with an android operating system version 10.Customer reported their freestyle libre 3 application "didn't sound the alarm".As a result, the customer was unable to monitor glucose with sensor readings and experienced sweating, requiring treatment of glucosprint by a non-healthcare provider.There was no report of death or permanent impairment associated with this event.
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