Model Number 72075-01 |
Device Problems
Unable to Obtain Readings (1516); Application Program Problem (2880)
|
Patient Problems
Pain (1994); Blurred Vision (2137); Dizziness (2194); Diabetic Ketoacidosis (2364); Polydipsia (2604)
|
Event Date 10/04/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Extended investigation is pending at this time.A follow up 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 manufacturing date does not apply.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.
|
|
Event Description
|
Customer reported that they ¿cannot start sensor¿ in use with google plus 1 with android operating system version 12.As a result, the customer was unable to monitor glucose with sensor readings and experienced symptoms of frequent urination, thirst, blurry vision, lightheaded, aches, and pain requiring treatment of insulin drip provided by a healthcare professional for a diagnosis of diabetic ketoacidosis (dka).An hcp meter reading of 1173 mg/dl was also obtained, the time of this reading was unspecified in relation to the medical event.Customer further reported they ¿been to the hospital 20 times in the last 14 months due to ketoacidosis¿.It was not directly related to being unable to start the sensor.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
An extended investigation was performed.The customer reported not being able to start the sensor with the freestyle libre 3 application.Attempted to replicate the customer's complaint using similar configurations samsung galaxy s10, android 12, 3.4.2.9593 and the reported issue was unable to be replicated and the system and functioned as intended.There were no issues identified with the freestyle libre 3 app during replication that would have led to the reported issue.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
Customer reported that they ¿cannot start sensor¿ in use with google plus 1 with android operating system version 12 , app version 3.4.2.9593.As a result, the customer was unable to monitor glucose with sensor readings and experienced symptoms of frequent urination, thirst, blurry vision, lightheaded, aches, and pain requiring treatment of insulin drip provided by a healthcare professional for a diagnosis of diabetic ketoacidosis (dka).An hcp meter reading of 1173 mg/dl was also obtained, the time of this reading was unspecified in relation to the medical event.Customer further reported they ¿been to the hospital 20 times in the last 14 months due to ketoacidosis¿.It was not directly related to being unable to start the sensor.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|
|