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 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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.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 high readings issue with the adc device was reported.Customer received unspecified higher sensor scan results compared to unspecified readings obtained on a competitor brand meter and experienced a loss of consciousness and hypoglycemia symptoms.Customer was unable to self-treat and required healthcare provider treatment of iv glucose for treatment of a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.A sensor reading of 200 mg/dl was compared to a healthcare meter reading of 75 mg/dl, the results, when plotted on a parkes error grid, fell into the 'd' zone showing the difference in values to be clinically significant.It is unknown when these readings were taken in relation the reported adverse event.
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A high readings issue with the adc device was reported.Customer received unspecified higher sensor scan results compared to unspecified readings obtained on a competitor brand meter and experienced a loss of consciousness and hypoglycemia symptoms.Customer was unable to self-treat and required healthcare provider treatment of iv glucose for treatment of a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.A sensor reading of 200 mg/dl was compared to a healthcare meter reading of 75 mg/dl, the results, when plotted on a parkes error grid, fell into the 'd' zone showing the difference in values to be clinically significant.It is unknown when these readings were taken in relation the reported adverse event.
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Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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