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

Model Number 71926-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problem Loss of consciousness (2418)

Event Date 09/09/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 325520392
• Report Number: 2954323-2023-45632
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599810009
• UDI-Public: 00357599810009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• 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
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 71926-01
• Device Lot Number: 2.7.3.3641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other