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.The product has been requested back for an investigation.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.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle 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.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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A social media complaint regarding high glucose sensor scan readings issue was reported with use of the abbott diabetes care (adc) device.The customer received a glucose sensor scan of 117 mg/dl when scanning the abbott diabetes care (adc) device, and after customer service follow-up, the customer stated they experienced experience a loss of consciousness.As a result, the customer was then treated with orange juice with a heaping tablespoon of sugar by a non-healthcare professional (non-hcp) and emergency services were called.Upon the arrival of emergency services, a blood glucose test of 26 mg/dl was obtained on the healthcare provider (hcp) meter while the glucose sensor scan was reading 117 mg/dl.When plotted on a parkes error grid, fall into the "d" zone, showing the difference in values to be clinically significant.After customer follow-up they reported that no further treatment was provided.There was no report of death or permanent impairment associated with this event.
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