Model Number 71992-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 04/18/2024 |
Event Type
Injury
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Event Description
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Customer reported the abbott diabetes care (adc) sensor did not penetrate the skin and therefore customer was unable to monitor glucose levels.As a result, the customer experienced a seizure, loss of consciousness, and was unable to self-treat, requiring a non-healthcare professional prior to contact emergency services (es).Upon arrival, an es healthcare professional (hcp) provided third-party treatment of "intravenous glucose" (dose unspecified).No further treatment was reported.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 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.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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors; no trends were identified that would indicate any product related issues.The device manufacturing date is unknown.The date entered in section h4 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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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 issues were observed.The sensor plug is fully seated.The watermark did not observed at the base of the sensor tail.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sensor pack (b)(6) has been returned and investigated.Visual inspection has been performed on the sensor pack and damage was observed.Lid was completely peeled off.Applicator (b)(6) has been returned and investigated.Visual inspection has been performed on the applicator and no issues were observed.The applicator has been fired correctly.Therefore, issue is not confirmed to use due to incorrect assembly method.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported the abbott diabetes care (adc) sensor did not penetrate the skin and therefore customer was unable to monitor glucose levels.As a result, the customer experienced a seizure, loss of consciousness, and was unable to self-treat, requiring a non-healthcare professional prior to contact emergency services (es).Upon arrival, an es healthcare professional (hcp) provided third-party treatment of "intravenous glucose" (dose unspecified).No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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