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 functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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 reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) 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 (adc) has been submitted.
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A low readings issue was reported with the abbott diabetes care (adc) device.It was reported, the customer was receiving unspecified sensor scan results perceived to be low when compared to unspecified readings obtained from the built-in reader.As a result, the customer experienced hyperglycemia and was unable to self-treat, requiring treatment with seven (7) iu of 'novorapid' (rapid acting insulin) administered by a non-healthcare professional (non-hcp).There was no report of death or permanent injury associated with this event.A blood glucose sensor scan result of 59 mg/dl was reported and compared to a blood glucose level result of 308 mg/dl obtained from the built-in reader, and when plotted on a parkes error grid fell into the "d" zone, showing the difference in values to be clinically significant.It is unknown if the values reported were obtained at the time of the medical event.
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