A low reading issue was reported with the abbott diabetes care (adc) device.A customer reported receiving an unspecified low scan on the sensor compared to unknown readings obtained from a competitor device.The customer experienced headache and nausea, and was unable to self-treat.The customer was seen at a hospital where a laboratory glucose result of 110 mg/dl in comparison to a sensor scan of 59 mg/dl.When the results were plotted on a parkes error grid, fell into the "c" zone showing the difference in values to be clinically significant.The customer was administered unspecified iv by a healthcare professional for the reported issue.No further information was 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 dhrs (device history review) for the libre sensor and sensor kits were reviewed and the dhrs showed the 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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