Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hemorrhage/Bleeding (1888); Loss of consciousness (2418)
|
Event Date 10/24/2023 |
Event Type
Injury
|
Event Description
|
A customer reported a bleeding issue with the adc device and experienced a loss of consciousness.The customer had contact with a healthcare professional (hcp), however, no treatment was reported.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
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 in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
|
|
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.
|
|
Event Description
|
A customer reported a bleeding issue with the adc device and experienced a loss of consciousness.The customer had contact with a healthcare professional (hcp), however, no treatment was reported.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the sensor, no issue were observed.The sensor plug was properly seated.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.No malfunction or product deficiency was identified.Unable to perform further investigation due to partial product returned.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.
|
|
Event Description
|
A customer reported a bleeding issue with the adc device and experienced a loss of consciousness.The customer had contact with a healthcare professional (hcp), however, no treatment was reported.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|