Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Cognitive Changes (2551); Convulsion/Seizure (4406)
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Event Date 07/31/2023 |
Event Type
Injury
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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after three days of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced a loss of consciousness, seizure, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of "chocolatine and juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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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 kit were reviewed and the dhrs showed the fs 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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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after three days of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced a loss of consciousness, seizure, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of "chocolatine and juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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