An unexpected application error message was reported with the adc device in use with a samsung galaxy s20 phone with android operating system version 13.Customer indicated "scan failed" message, the customer was unable to monitor glucose with sensor readings and experienced symptoms of dizziness and a loss of consciousness, requiring treatment of chocolates and juice by their spouse.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.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 an "unexpected application error" message with the freestyle libre 2 application.Product quality engineering attempted to replicate the reported issue using a cellular device not identical to the actual device, but which shares relevant characteristics with the device involved and google pixel 4a, android 13 ,2.10.1.10406, and was not able to reproduce the complaint.There were no issues identified with the freestyle libre 2 app during replication that would have led to the reported issue.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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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