The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.Sensor kit expiration date is 31-oct-2023.The medical event associated with this case occurred on (b)(6) 2023 which confirms the usage of the device beyond the useful life of the device.No additional investigation are required as the device met its specification lifespan.All pertinent information available to abbott diabetes care has been submitted.
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A high reading issue was reported with the adc device.Customer reported unspecified high sensor reading compared to unspecified readings from a competitor brand meter.As a result, the customer reported experiencing convulsions, "eyes blacked out", and felt like they "cut out".No further details were provided, and the customer declined to provide additional information regarding the event.There was no report of death or permanent impairment associated with this event.
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