Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
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Event Date 11/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 dhrs (device history review) for the libre sensor and 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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Event Description
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A caregiver reported the customer received a "replace sensor" message on the same day of applying the freestyle libre 2 sensor.Customer experienced a loss of consciousness and seizure, and required third-party treatment of glucagon and food.There was no report of death or permanent injury associated with this event.
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Event Description
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A caregiver reported the customer received a "replace sensor" message on the same day of applying the freestyle libre 2 sensor.Customer experienced a loss of consciousness and seizure, and required third-party treatment of glucagon and food.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)(4), has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection was performed on the sensor plug assembly, no issues were observed.Sim vivo testing was performed and all results were within range specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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