Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 12/18/2020 |
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 there was no indication that the product did not meet specification.Dhrs (device history review) 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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Event Description
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A high readings issue was reported with use of the adc freestyle libre 2 sensor.The customer reported receiving a high reading of 97 mg/dl from the sensor and experienced a loss of consciousness and was administered a glucose injection by his wife as treatment.There was no report of death or permanent injury associated with this event.
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Event Description
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A high readings issue was reported with use of the adc freestyle libre 2 sensor.The customer reported, receiving a high reading of 97 mg/dl from the sensor.And experienced a loss of consciousness.And was administered a glucose injection by his wife 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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Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing.While in the test fixture, all results were within specification.The issue is therefore, not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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