MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE 3; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR US

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

My complaint is about the abbott freestyle libre 3 glucose monitor.I am on my 3rd libre 3 glucose monitor.This is the product that by my insurance company (b)(6) and doctor approved.My phone is an android galaxy s21 5g.My complaint is about the low glucose alarm function.Last night (this is not the first time this has happened) the low glucose alarm went off 4 times throughout the night.It said my level was in the 50's.I got up did a finger stick check each time with my livongo meter and it said my level was between 170 and 200.I could not turn the low glucose alarm off, so that it did not wake myself and my husband up.I had to turn off my phone completely.I do not like to do that because i have elderly family and children that might need to reach me.Like i said before this is not the first night i have had to deal with a false low alarm.Also, the false readings make me question the accuracy of the monitor.Which can be potentially dangerous.If i had known the difficulty using this system i probably wouldn't have bothered.The monitor's cost me $40 each.I do like knowing where my blood sugar levels are throughout the day.When it works it is a great tool to keep your blood sugar at a safe level.I will send a copy of my complaint to the abbott company.I doubt if anything will be done, but i know i am not the only one with this complaint.(b)(6).Reference reports: mw5118300, mw5118302.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR US
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 17106890
• MDR Text Key: 317066249
• Report Number: MW5118301
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White