Model Number 71992-01 |
Device Problem
Failure to Fire (2610)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
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Event Date 07/17/2023 |
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.There was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor kit was reviewed and the dhrs showed the freestyle 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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Customer reported attempting to apply an adc device and being unsuccessful due to the sensor being stuck on the applicator, and as a result of being unable to monitor glucose levels, experiencing a loss of consciousness, feeling dizzy, and sweating.Customer had contact with a hcp who provided "sweets", glucose injection and oral glucose.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor and no issues were observed.The sensor plug was properly seated.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Further investigation was not performed due to no product returned.Therefore, issue is closed to no product returned.If the partial 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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Customer reported attempting to apply an adc device and being unsuccessful due to the sensor being stuck on the applicator, and as a result of being unable to monitor glucose levels, experiencing a loss of consciousness, feeling dizzy, and sweating.Customer had contact with a hcp who provided "sweets", glucose injection and oral glucose.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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