A high readings issue was reported with use of the adc device.The customer obtained an unspecified high sensor scan reading and experienced symptoms of cold sweat, and slow speech.The customer had contact with a healthcare professional (hcp) who performed a blood glucose reading and administered glucose as treatment for hypoglycemia diagnosis.There was no report of death or permanent impairment associated with this event.A sensor scan result of 386 mg/dl was compared to a reading of 51 mg/dl obtained on healthcare professional (hcp) meter.When the results were plotted on a parkes error grid, fell into the "d" zone showing the difference in values to be clinically significant.However, it is unknown when these readings were taken in relation to the reported adverse event.
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A high readings issue was reported with use of the adc device.The customer obtained an unspecified high sensor scan reading and experienced symptoms of cold sweat, and slow speech.The customer had contact with a healthcare professional (hcp) who performed a blood glucose reading and administered glucose as treatment for hypoglycemia diagnosis.There was no report of death or permanent impairment associated with this event.A sensor scan result of 386 mg/dl was compared to a reading of 51 mg/dl obtained on healthcare professional (hcp) meter.When the results were plotted on a parkes error grid, fell into the "d" zone showing the difference in values to be clinically significant.However, it is unknown when these readings were taken in relation to the reported adverse event.
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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