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 reported having unexpected application error.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 android 13 ,2.10.1.10406.The reported issue was unable to be replicated and the system functioned as intended.There were no issues identified with the freestyle libre 2 app during replication that would have led to the reported issue.Therefore, the issue is not confirmed.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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A "scan failed" application error message was reported with the adc device in use with a samsung galaxy s20 phone with android operating system version 13.As a result, the customer was unable to monitor glucose with sensor readings and experienced hypoglycemia with symptoms described as dizziness and a loss of consciousness, requiring non-hcp administration of chocolate, a kit-kat, and juice for treatment.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
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