MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY; SENSOR, GLUCOSE, INVASIVE

Model Number ART28261 REV A 10/17

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

I am advising the fda to further review the abbott freestyle libre 14 day system.I have been a user of this for just over one year.In that time, i have encountered multiple sensor issues.Some giving inaccurate reading as confirmed by a separate finger stick system.I've also had 2 sensors stop working completely in under a week.After reviewing multiple websites i'm finding that i'm not alone with this experience.This is proving to be a very unreliable system.Their website is misleading by stating you can reduce finger pricks.What's the point of the system if it's always so far off that you have to verify by a finger stick.It has been my experience that this system is unreliable and costly.If it hasn't happened yet someone will make a bad diabetic management decision based on the inaccuracies in the system.Today i was left without a way to test due to another unexpected failure.I will no longer rely on the system and will carry a second tester.Once my remaining sensors fail, i will be throwing this system away.It is that bad.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11776547
• MDR Text Key: 249435689
• Report Number: MW5101158
• Device Sequence Number: 1
• Product Code: MDS
• 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: 05/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ART28261 REV A 10/17
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 79