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

Model Number 72154-01

Device Problems Unable to Obtain Readings (1516); Application Program Problem (2880)

Patient Problems Fever (1858); Dizziness (2194); Loss of consciousness (2418)

Event Date 10/17/2023

Event Type  Injury  

Event Description

Abbott diabetes care (adc) received a social media complaint that reported a communication error issue with the freestyle libre 3 app in use with an iphone 13 pro phone with an ios operating system version 17.0.3.The customer was unable to access their freestyle librelink account and as a result, the customer was unable to monitor their glucose.The customer experienced symptoms of dizziness, fever, and a loss of consciousness however, there was no third-party medical intervention reported.No further information was obtained as the reporter abandoned their social media post.There was no report of death or permanent impairment associated with this event.

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.

Manufacturer Narrative

The customer reported communication error and was unable to access the freestyle libre 3 account.Attempted to replicate the customer's complaint using similar configurations iphone 13 mini, ios 17.0.3, 3.5.0.8863 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

Abbott diabetes care (adc) received a social media complaint that reported a communication error issue with the freestyle libre 3 app in use with an iphone 13 pro phone with an ios operating system version 17.0.3.The customer was unable to access their freestyle librelink account and as a result, the customer was unable to monitor their glucose.The customer experienced symptoms of dizziness, fever, and a loss of consciousness however, there was no third-party medical intervention reported.No further information was obtained as the reporter abandoned their social media post.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: 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: 18105088
• MDR Text Key: 327881778
• Report Number: 2954323-2023-49409
• Device Sequence Number: 1
• Product Code: QLJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72154-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other