A low reading issue was reported with use of the adc device.The customer received an unspecified low sensor scan results when compared to readings obtained on an adc meter.As a result, customer experienced symptoms described as "loss of consciousness as customer felt pain in both legs and arms, body swelled and blurry vision." however, no treatment by a third-party and/or healthcare professional was reported for this issue.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 functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.At this time product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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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A low reading issue was reported with use of the adc device.The customer received an unspecified low sensor scan results when compared to readings obtained on an adc meter.As a result, customer experienced symptoms described as "loss of consciousness as customer felt pain in both legs and arms, body swelled and blurry vision." however, no treatment by a third-party and/or healthcare professional was reported for this issue.There was no report of death or permanent impairment associated with this event.
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Sensor (b)(6)has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.A watermark did not observed at the base of the tail.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Performed an smu (source measurement unit) test using connector key to ensure the sensor's electronics were functioning correctly and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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