Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Headache (1880); Hyperglycemia (1905)
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Event Date 04/16/2024 |
Event Type
Injury
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Event Description
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An error message was reported with the abbott diabetes care (adc) device.Customer received a "check sensor" message and was unable to obtain readings.As a result, customer experienced "no way to control their head", "headaches" and was unable to self-treat, requiring going to the emergency room (er).At the er, a healthcare professional (hcp) performed a blood glucose measurement with result of 400 mg/dl, prior to providing third-party treatment of "insulin injection" (type/dose unspecified) for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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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 it has been determined that 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.All pertinent information available to abbott diabetes care has been submitted.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor and no physical damage was observed with the sensor patch.Extracted data from returned sensor using approved software.Sensor found to be in state 1 (storage state) and insertion failures was observed in the event log.Watermark was not observed at the base of the tail.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.This complaint is not confirmed due to tail not properly inserted all pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the abbott diabetes care (adc) device.Customer received a "check sensor" message and was unable to obtain readings.As a result, customer experienced "no way to control their head", "headaches" and was unable to self-treat, requiring going to the emergency room (er).At the er, a healthcare professional (hcp) performed a blood glucose measurement with result of 400 mg/dl, prior to providing third-party treatment of "insulin injection" (type/dose unspecified) for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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