A low readings issue with the adc device was reported.The customer reported receiving lower sensor scan result in the 50¿s mg/dl and experienced stomach pain, tiredness, and feeling sick.It was indicated that the customer self-treated by "eating a lot" (unspecified food.) the customer then contacted a healthcare professional (hcp) who suggested for the customer to visit the emergency room (er).Upon arrival to the er, the customer was treated with an unspecified intravenous (iv) medication by a hcp.No further details were provided.There was no report of death or permanent impairment associated with this event.
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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.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kits were reviewed and the dhrs showed the freestyle libre sensor and sensor kits passed all tests prior to release.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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