A delivery delay with a replacement abbott diabetes care (adc) device was reported.The replacement device was issued due to a "scan again in 10 minutes" message displaying and was unable to test.Due to delivery delay, customer experienced a loss of consciousness, "loss of awareness", and was unable to self-treat, requiring third-party treatment of a "fruit juice" by a non-healthcare professional.There was no report of death or permanent injury 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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.If the product is returned, a physical investigation will be performed and a follow-up report submitted.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.All pertinent information available to abbott diabetes care has been submitted.
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A delivery delay with a replacement abbott diabetes care (adc) device was reported.The replacement device was issued due to a "scan again in 10 minutes" message displaying and was unable to test.Due to delivery delay, customer experienced a loss of consciousness, "loss of awareness", and was unable to self-treat, requiring third-party treatment of a "fruit juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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