Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Compatibility Problem (2960)
|
Patient Problem
Loss of consciousness (2418)
|
Event Date 04/25/2023 |
Event Type
Injury
|
Event Description
|
An error message was reported with the abbott diabetes care (adc) device.Customer purchased a device, while travelling, which was not compatible with their application and they were unable to obtain readings or monitor glucose levels.As a result, customer experienced a loss of consciousness and no third-party treatment was reported.There was no report of death or permanent impairment 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 of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg 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 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
|
An error message was reported with the abbott diabetes care (adc) device.Customer purchased a device, while travelling, which was not compatible with their application and they were unable to obtain readings or monitor glucose levels.As a result, customer experienced a loss of consciousness and no third-party treatment was reported.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|