Model Number 71940-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Polydipsia (2604); Convulsion/Seizure (4406)
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Event Date 04/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A low reading issue was reported with the adc sensor.Customer reported receiving a sensor scan result of 2.8 mmol/ (50 mg/dl), drinking juice, and then going to sleep.During the night, customer experienced a seizure and awoke feeling thirsty and in a state of hyperglycemia.Customer self-treated with "seizure medication" and other medications and no third-party treatment 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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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs 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 low reading issue was reported with the adc sensor.Customer reported receiving a sensor scan result of 2.8 mmol/ (50 mg/dl), drinking juice, and then going to sleep.During the night, customer experienced a seizure and awoke feeling thirsty and in a state of hyperglycemia.Customer self-treated with "seizure medication" and other medications and no third-party treatment 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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