Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 01/24/2021 |
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 in 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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An alarm issue was reported with the adc freestyle libre 2 sensor.Customer reported the low glucose alarm did not sound and customer experienced seizure and a fall due to loss of consciousness.Customer was treated with glucose gel by his wife and had contact with doctor who treated him with morphine and sutured the wound on his face after the fall.There was no report of death or permanent injury associated with this event.
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Event Description
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An alarm issue was reported with the adc freestyle libre 2 sensor.Customer reported the low glucose alarm did not sound and customer experienced seizure and a fall due to loss of consciousness.Customer was treated with glucose gel by his wife and had contact with doctor who treated him with morphine and sutured the wound on his face after the fall.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Additional information: section h4 (device manufactured date) has been updated based on the extended investigation.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 the specifications.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.The customer reported they did not receive any alarms in their librelink application.The product quality engineer did not identify any issues with the librelink app.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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Search Alerts/Recalls
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