MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3 APPLICATION; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	72075-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Application Program Problem (2880)
Health Effect - Clinical Codes	Pain (1994); Blurred Vision (2137); Dizziness (2194); Elevated ketones/Diabetic Ketoacidosis (2364); Polydipsia (2604)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: FREESTYLE LIBRE 3 APPLICATION
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18022868
• Report Number: 2954323-2023-47528
• Device Sequence Number: 15374770
• Product Code: QLG
• UDI-Device Identifier: 00357599816001
• UDI-Public: 00357599816001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72075-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown