Model Number 71940-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Convulsion/Seizure (4406)
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Event Date 11/28/2021 |
Event Type
Injury
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Event Description
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An error message issue was reported with the freestyle libre sensor.The customer obtained a "replace sensor" message upon scanning on the seventh day of wear and as a result, was unable to obtain glucose scans.The customer experienced seizure and subsequently fell down.The customer's daughter called an ambulance, but customer reported being to self-treat with glucose aide and ambulance was "called off".No additional 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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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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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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.An extended investigation has been performed for the reported complaint and it has been 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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An error message issue was reported with the freestyle libre sensor.The customer obtained a "replace sensor" message upon scanning on the seventh day of wear and as a result, was unable to obtain glucose scans.The customer experienced seizure and subsequently fell down.The customer's daughter called an ambulance, but customer reported being to self-treat with glucoseaide and ambulance was "called off".No additional 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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