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.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigations planned.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 readings issue was reported with the adc device.Customer reported receiving unspecified low readings obtained on the adc sensor scan in comparison to unspecified readings obtained on a competitor brand device.As a result, the customer experienced hypoglycemia with symptoms described as "disarticulation of the limbs," and a loss of consciousness and was unable to self-treat.Emergency services were called and upon their arrival an initial hcp meter reading of 26 mg/dl was obtained and the customer was administered intravenous glucose and a glucagen injection for treatment by a hcp.Approximately 15 minutes later, a secondary hcp meter reading of "40-50" mg/dl was obtained but no further treatment was indicated.There was no report of death or permanent injury associated with this event.
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