MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. ABBOTT FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE

Model Number FREESTYLE LIBRE 2

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

The abbott continuous glucose monitor sensor installed on (b)(6) 2022 failed after 2 days, the last 2 sensor before this one also failed, making a total of 8 failed sensors in less than 5 months.This appears to be a failure rate greater than 50%.Fda safety report id# (b)(4).

• Brand Name: ABBOTT FREESTYLE LIBRE 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14565901
• MDR Text Key: 293169635
• Report Number: MW5110004
• Device Sequence Number: 1
• Product Code: MDS
• 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: 05/26/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FREESTYLE LIBRE 2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2022
• Patient Sequence Number: 1
• Treatment: BISOPROLOL ; CITALOPRAM ; INSULIN ; METFORMIN ; PRADAXA; ROSUVASTATIN ; VITAMIN D
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic
• Patient Race: White