Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)
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Event Date 12/15/2021 |
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.The dhrs (device history review) 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 was not able to obtain a scan while using the adc freestyle libre 2 sensor.As a result, on (b)(6) 2021, the customer experienced dizziness and had a seizure and was provided an injection of "glucagenic hypokite" by a non-hcp for the treatment of hypoglycemia.No further information was reported.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 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).Attempted communication between returned sensor and known good reader.Reader successfully communicated with the returned sensor.Scan timeout error message was not observed.Therefore, this 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 was not able to obtain a scan while using the adc freestyle libre 2 sensor.As a result, on 15dec2021, the customer experienced dizziness and had a seizure and was provided an injection of "glucagenic hypokite" by a non-hcp for the treatment of hypoglycemia.No further information was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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