MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; DATA MANAGEMENT SYSTEM

Model Number	71926-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	11/27/2023
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 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.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone se phone with ios operating system version 16.5.1.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness, and was unable to self-treat, requiring third-party treatment of "re-sugared" by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The freestyle librelink app complaint was investigated and determined that there were no issues with the librelink application that would have led to the complaint.The user reported missing high or low glucose alarms.Attempted to replicate the user¿s complaint using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone se phone with ios operating system version 16.5.1, app version 2.10.2.7677.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness, and was unable to self-treat, requiring third-party treatment of "re-sugared" by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone se phone with ios operating system version 16.5.1, app version 2.10.2.7677.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness, and was unable to self-treat, requiring third-party treatment of "re-sugared" by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The freestyle libre 2 app complaint was investigated and determined that there were no issues with the libre 2 application that would have led to the complaint.The user reported missing high or low glucose alarm.Attempted to replicate the user¿s complaint using similar configuration of iphone 11 pro, ios 16.6, 2.10.2.7677 and the reported issue was unable to be replicated and the system functioned as intended.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Common Device Name: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18333868
• Report Number: 2954323-2023-54083
• Device Sequence Number: 4479235
• Product Code: PZE
• UDI-Device Identifier: 00357599810009
• UDI-Public: 00357599810009
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P160030
• 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,Followup
• Report Date (Section B): 03/19/2024
• 2 Devices were Involved in the Event: 1 2

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: 71926-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/07/2024; 03/11/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/15/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Patient Sex: Unknown