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¿s product has been requested for investigation.At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date of event is unknown.The date entered in section b3 is based on the customer report of "middle of march".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 xiaomi redmi 10 phone with android 11 operating system version 2.10.1.10406.The sensor's low and high glucose alarms did not sound and the customer was not alerted of changes in glucose level.As a result, the customer experienced blurry vision, nausea, and a loss of consciousness however, the customer was able to self-treat with sugar water.There was no report of death or permanent impairment associated with this event.
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