An alarm issue was reported with the adc device.The low glucose alarm did not sound and as a result, customer was not alerted of changes in glucose level and experienced a loss of consciousness and a fall and was unable to self-treat, requiring treatment of glucose intravenously and stitches to their head due to the fall by a healthcare professional.There was no report of death or permanent impairment associated with this event.
|
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 (device history review) showed the fs libre sensor and sensor kit passed all tests prior to release.Dhrs (device history review) for the libre reader were reviewed and the dhrs (device history review) showed the libre reader 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.
|
An alarm issue was reported with the adc device.The low glucose alarm did not sound and as a result, customer was not alerted of changes in glucose level and experienced a loss of consciousness and a fall and was unable to self-treat, requiring treatment of glucose intravenously and stitches to their head due to the fall by a healthcare professional.There was no report of death or permanent impairment associated with this event.
|