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

Model Number	72075-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hyperglycemia (1905); Convulsion/Seizure (4406)
Date of Event	04/01/2024
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 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
An incompatibility issue was reported with the abbott diabetes care (adc) application, in use with an unspecified phone.As a result, the customer was unable to check glucose and experienced a seizure however, the customer was able to self treat with "fast acting" insulin provided by a non-healthcare professional.The customer then had a contact with a healthcare professional (hcp) who obtained a blood glucose result of 286 mg/dl but no treatment was reported.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
An incompatibility issue was reported with the abbott diabetes care (adc) application, in use with an unspecified phone.As a result, the customer was unable to check glucose and experienced a seizure however, the customer was able to self treat with "fast acting" insulin provided by a non-healthcare professional.The customer then had a contact with a healthcare professional (hcp) who obtained a blood glucose result of 286 mg/dl but no treatment was reported.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The user reported unknown or unspecified issue.The reported issue was investigated and attempted to be replicated.The reported configuration was not compatible with the customer's reported application.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• 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: 19165383
• Report Number: 2954323-2024-13898
• Device Sequence Number: 7873626
• Product Code: QBJ
• UDI-Device Identifier: 00357599816001
• UDI-Public: 00357599816001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223435
• 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): 06/27/2024

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: 04/01/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Patient Sex: Female