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

Model Number 72077-01

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

Patient Problems Nausea (1970); Confusion/ Disorientation (2553)

Event Date 08/12/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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 11 with ios operating system version 16.6.The high glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced nausea, confusion ¿like drunk¿.Customer was assisted, by partner, with unspecified treatment.There was no report of death or permanent impairment associated with this event.

Event Description

An alarm issue was reported with the adc device in use with iphone 11 with ios operating system version 16.6; app version 3.4.0.7228.The high glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced nausea, confusion ¿like drunk¿.Customer was assisted, by partner, with unspecified treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and it has been determined that there were no issues with the librelink application that would have led to the complaint.The user reported missing high and low glucose alarms with the freestyle librelink application.Successfully scanned and received high and low glucose alarm notifications and glucose reading using a similar configuration (iphone 13 mini, ios 16.2, 3.4.0.7228) and unable to reproduce the complaint.All pertinent information available to abbott diabetes care has been submitted.

• 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: 17694625
• MDR Text Key: 322779513
• Report Number: 2954323-2023-39192
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• 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: 10/16/2023

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: 72077-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female