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 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.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.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.
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A low reading issue was reported with the adc device.A customer reported receiving low scan of 54 mg/dl compared to a adc meter blood glucose test of 501 mg/dl.The results were plotted on a parkes error grid and fell into the "d" zone showing the difference in values to be clinically significant.The customer experienced blurred vision, polydipsia, polyuria, ¿general disease¿ (unspecified), sleeping and was unable to self-treat.The customer made hcp contact where a blood glucose test of result of 600 mg/dl was obtained on the healthcare meter, however no comparison sensor scan was performed.The customer then received fast-acting insulin and water by the hcp for treatment.The customer reportedly received both third-party and hcp treatment.However, no further treatment information was provided.There was no report of death or permanent injury associated with this event.
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