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.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader and kit pack dhr for cable and adapter were reviewed and the dhr showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion.As a result, the customer experienced hypoglycemia with symptoms of loss of consciousness, dizziness, nausea, and was unable to self-treat.The customer had contact with a healthcare professional who obtained laboratory blood glucose readings of "92 mg/dl to 137 mg/dl and back to 92 mg/dl." no third-party treatment was reported.There was no report of death or permanent impairment associated with this event.
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