Model Number 71733-01 |
Device Problems
Computer Software Problem (1112); Unable to Obtain Readings (1516); Application Program Version or Upgrade Problem (2881)
|
Patient Problems
Fall (1848); Loss of consciousness (2418); Convulsion/Seizure (4406)
|
Event Date 02/25/2022 |
Event Type
Injury
|
Event Description
|
A caregiver reported information did not transfer using librelink up with freestyle librelink.As a result, on (b)(6) 2022, the customer had a fall, seizure, and a loss of consciousness.The red cross was called and provided the customer unspecified intravenous fluids for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
The product data has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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
|
A caregiver reported information did not transfer using librelink up with freestyle librelink.As a result, on (b)(6) 2022, the customer had a fall, seizure, and a loss of consciousness.The red cross was called and provided the customer unspecified intravenous fluids for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
The user reported that they are unable to receive notifications in freestyle librelinkup.Attempts to replicate the users compaint using a similar configuration was performed and notifications were received after scanning a sensor.Investigation was unable to replicate the complaint therefore, the issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.
|
|
Search Alerts/Recalls
|