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

Model Number	71926-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	09/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The investigation was able to successfully start a libre 2 sensor, receive glucose readings and alarm notifications in the application using a similar configuration (iphone 11, ios 15.6.1, 2.7.3.3641) and was not able to confirmed the reported complaint.No failure was found.The device manufacturing 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 adc device in use with iphone se with ios 15.6.1 (system version 2.7.3.3641).The customer experienced a signal loss and could not obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced loss of consciousness however, there was no report of third-party medical intervention.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2 APP
• 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: 17922988
• Report Number: 2954323-2023-45632
• Device Sequence Number: 17841360
• Product Code: QLG
• UDI-Device Identifier: 00357599810009
• UDI-Public: 00357599810009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• 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
• Report Date (Section B): 10/12/2023

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: 71926-01
• Device Lot Number: 2.7.3.3641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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: Other
• Patient Sex: Unknown