Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Loss of consciousness (2418)
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Event Date 01/13/2024 |
Event Type
Injury
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Event Description
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A customer reported experiencing bleeding after applying the adc device.As a result, the customer experienced symptoms of hyperglycemia, a loss of consciousness, and reported being able to self-treat.The customer had contact with a non-healthcare professional third-party who "followed protocol" as treatment.There was no report of death or permanent injury 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 for this complaint.An extended investigation has been performed for the reported complaint.The dhrs (device history record) for the libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the libre sensor and libre 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 performed on the returned sensor and no issue was observed.The sensor plug is properly seated.Visual inspection has been performed on the sensor plug, no failure modes were observed.Further investigation was not performed due to no product returned.Therefore, issue is closed to no product returned.If the partial 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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Event Description
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A customer reported experiencing bleeding after applying the adc device.As a result, the customer experienced symptoms of hyperglycemia, a loss of consciousness, and reported being able to self-treat.The customer had contact with a non-healthcare professional third-party who "followed protocol" as treatment.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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