Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 02/25/2022 |
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 determined that there was no indication that the product did not meet specification.Dhrs for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 customer reported lower values when scanning the adc device.On (b)(6) 2022, as a result, the customer had a fall and lost consciousness.An ambulance was called and provided the customer intravenous glucose for the treatment of hypoglycemia.No further information was provided.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.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported lower values when scanning the adc device.On (b)(6) 2022, as a result, the customer had a fall and lost consciousness.An ambulance was called and provided the customer intravenous glucose for the treatment of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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