A low glucose sensor scan readings issue was reported with the abbott diabetes care (adc) device when compared to a blood glucose test that was performed on a health care provider¿s (hcp) meter.The caregiver mentioned that the customer received an unspecified glucose sensor scan value that was perceived to be low, and experienced symptoms described as being ¿tired¿ and as a result, was unable to provide self-treatment.The customer contacted a healthcare professional (hcp) where an unspecified blood glucose test result was obtained on the hcp meter and the customer was administered insulin (type/dose unknown) for treatment.No further information or interventions was reported.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.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 fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care (adc) has been submitted.
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Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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A low glucose sensor scan readings issue was reported with the abbott diabetes care (adc) device when compared to a blood glucose test that was performed on a health care provider¿s (hcp) meter.The caregiver mentioned that the customer received an unspecified glucose sensor scan value that was perceived to be low, and experienced symptoms described as being ¿tired¿ and as a result, was unable to provide self-treatment.The customer contacted a healthcare professional (hcp) where an unspecified blood glucose test result was obtained on the hcp meter and the customer was administered insulin (type/dose unknown) for treatment.No further information or interventions was reported.There was no report of death or permanent impairment associated with this event.
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