An alarm issue was reported with the adc device.The low glucose alarm did not sound, and the customer was unaware of changes in glucose levels.As a result, the customer experienced a loss of consciousness and fell into a coma.The customer was seen at a hospital where they were hospitalized and was resuscitated for the diagnosis of hypoglycemia.It was further reported that at the time of the call, the customer was still in a coma at the hospital.No further treatment information was provided.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 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.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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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An alarm issue was reported with the adc device.The low glucose alarm did not sound, and the customer was unaware of changes in glucose levels.As a result, the customer experienced a loss of consciousness and fell into a coma.The customer was seen at a hospital where they were hospitalized and was resuscitated for the diagnosis of hypoglycemia.It was further reported that at the time of the call, the customer was still in a coma at the hospital.No further treatment information was provided.There was no report of death or permanent impairment associated with this event.
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