MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71926-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Abbott diabetes care received a medwatch report which reported the following information: an alarm issue was reported with the abbott diabetes care (adc) device in use with unknown phone with unknown operating system version.The low and high glucose alarms did not sound "since app update" and customer was not alerted of changes in glucose level.No contact information was provided to adc; therefore, adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
This complaint was received via user report and has been reported to fda.Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or 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.The operating system is unknown so product information provided is for ios.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care received a medwatch report which reported the following information: an alarm issue was reported with the abbott diabetes care (adc) device in use with unknown phone with unknown operating system version.The low and high glucose alarms did not sound "since app update" and customer was not alerted of changes in glucose level.No contact information was provided to adc; therefore, adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
The freestyle libre 2 app complaint was investigated and determined that there were no issues with the freestyle libre 2 app that would have led to the complaint.The user reported missing high and low glucose alarms.Attempted to replicate the user¿s complaint using similar configuration of iphone 13 mini (ios 17.0.3, 2.7.5.4061) and a samsung galaxy a52 (android 13, 2.7.5.7252) 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: FLASH GLUCOSE MONITORING 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: 18443361
• Report Number: 2954323-2024-00268
• Device Sequence Number: 6883594
• Product Code: QLG
• UDI-Device Identifier: 00357599810009
• UDI-Public: 00357599810009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 71926-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2023
• 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
• Patient Sex: Unknown