MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 CGM SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problems Product Quality Problem (1506); Defective Device (2588); Activation Failure (3270)

Patient Problem Anxiety (2328)

Event Type  malfunction  

Event Description

Re.Abbott "freestyle libre 2" cgm(continuous glucose monitor) sensors (prescription): for about the last year, approximately 80% of abbott's sensors have proven faulty before their stated 14-day run time.Until(b)(6) 2023, all were replaced free of charge per each of my calls to customer service, whereby they requested extensive details which i supplied; i have kept meticulous records of these calls and saved box portions featuring sensor exp.Dates, lot and serial numbers.But on (b)(6) 2023, when i called to report the latest faulty sensor, supervisor (b)(6) said that they would no longer replace my faulty sensors as i had reached their limit of 10 faulty sensors per 6 months.As an insulin dependent person with type 1 diabetes, i rely on my fda approved cgm to make treatment decisions throughout the day, and the number of faulty abbott sensors has severely impacted the ability to manage my condition, not to mention the worry and additional cost of using many extra test strips with another meter for verification/calibration.My goal is to have a working cgm and that those that fail be replaced by the manufacturer, but in this case, the higher the failure rate the more abbott penalizes customers such as myself (fyi: high failure rates for dexcom and abbott sensors abound in patient discussion forums).Can the fda please help by: requiring lower sensor failure rates; requiring free replacement irrespective of # of faulty sensors; requiring abbott to inform customers of their findings on faulty sensors returned per abbott's request; and requiring that faulty sensor data be published for easy access by customers? thank you.Reference reports: mw5118917, mw5118918, mw5118919, mw5118920, mw5118921, mw5118922, mw5118924, mw5118925, mw5118926.

• Brand Name: FREESTYLE LIBRE 2 CGM SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17225648
• MDR Text Key: 318243081
• Report Number: MW5118923
• 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: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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
• Treatment: NP THYROID TABLETS; OCCASIONAL: MAGNESIUM,; VITAMIN D
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White