Model Number 71992-01 |
Device Problem
No Device Output (1435)
|
Patient Problem
Loss of consciousness (2418)
|
Event Date 07/01/2022 |
Event Type
Injury
|
Event Description
|
A customer reported an unspecified issue with the adc device and that it's not working.The customer further reported experiencing a loss of consciousness and had to go to the emergency room for the reported issue however, no further details were provided.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 is the date abbott diabetes care became aware of the event.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.
|
|
Manufacturer Narrative
|
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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 an unspecified issue with the adc device and that it's not working.The customer further reported experiencing a loss of consciousness and had to go to the er for the reported issue however, no further details were provided.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|