Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Visual Disturbances (2140); Sweating (2444); Shaking/Tremors (2515)
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Event Date 09/30/2020 |
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 device mfg date 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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Customer reported freestyle libre 2 sensor did not alarm for low glucose and because of this, she experienced low blood glucose with symptoms described as sweating, strong trembling, and visual disturbances.Customer was incapable of self-treating and was seen at a hospital where she was treated with oral grape sugar, cola, and intravenous fluids.There was no report of death or permanent injury associated with this event.
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Event Description
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Customer reported freestyle libre 2 sensor did not alarm for low glucose and because of this, she experienced low blood glucose with symptoms described as sweating, strong trembling, and visual disturbances.Customer was incapable of self-treating and was seen at a hospital where she was treated with oral grape sugar, cola, and intravenous fluids.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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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 (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.A tripped trend review was performed for the reported complaint and libre reader, and there were no adverse trends that indicate any potential product related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.
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Search Alerts/Recalls
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