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 Resultor 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

0 Patients were 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

• Device Model Number: ART28261 REV A 10/17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage