A high readings issue with the adc device was reported.Customer received unspecified higher sensor scan results compared to unspecified blood glucose readings obtained on a competitor brand meter.Customer initially treated themselves with an insulin injection and experienced symptoms described as severe hypoglycemia, "on the border of fainting" and discomfort.The customer then treated themselves with baqsinimi, a glucagon nasal spray, and as they did not notice a significant change in their blood glucose levels; they called the paramedics.The customer was taken to the hospital where they received an infusion of glucose as treatment by a healthcare professional.The customer additionally reported blood glucose reading of 95 mg/dl obtained on an hcp meter.No further treatment was reported.There was no report of death or permanent impairment associated with this 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 reviews) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs (device history reviews) showed the fs 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.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 blood glucose readings obtained on a competitor brand meter.Customer initially treated themselves with an insulin injection and experienced symptoms described as severe hypoglycemia, "on the border of fainting" and discomfort.The customer then treated themselves with baqsinimi, a glucagon nasal spray, and as they did not notice a significant change in their blood glucose levels; they called the paramedics.The customer was taken to the hospital where they received an infusion of glucose as treatment by a healthcare professional.The customer additionally reported blood glucose reading of 95 mg/dl obtained on an hcp meter.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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