Model Number 71992-01 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019)
|
Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
|
Event Date 12/26/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
An alarm issue was reported with the adc device.The low glucose alarm did not sound and customer was unaware of changes in glucose levels.As a result, customer experienced a loss of consciousness and was unable to self-treat, requiring hcp treatment of 1.1 oz.Of liquid glucose orally.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Event Description
|
An alarm issue was reported with the adc device.The low glucose alarm did not sound and customer was unaware of changes in glucose levels.As a result, customer experienced a loss of consciousness and was unable to self-treat, requiring hcp treatment of 1.1 oz.Of liquid glucose orally.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|