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

Lot Number KTP005908

Device Problems Product Quality Problem (1506); Sensing Intermittently (1558); Activation Failure (3270)

Patient Problem Anxiety (2328)

Event Date 04/14/2023

Event Type  Injury  

Event Description

Reporter calling to report a problem with her libre 2 sensor.She states she applied the sensor to her arm on (b)(6) 2023, however the sensor failed to initialize or set up appropriately.She states that she has been receiving error messages ever since and that it still won't finish the setup process even this morning (b)(6) 2023.Reporter states the sensor is currently applied to her arm.She woke up on (b)(6) 2023 feeling "a little nervous, anxious, like my sugar was low" and ate some food.She did not check her blood sugar level, however.She states she felt better after eating food.She is frustrated because she has experienced "many" sensor problems with the freestyle libre 2 over many months.She reports that some sensors last all fourteen days while other times, the sensor fails immediately after insertion and will not complete the setup process.She states the senors are expensive and constantly replacing them is a financial burden that is unfair to her.

• Brand Name: FREESTYLE LIBRE 2 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16753821
• MDR Text Key: 313539166
• Report Number: MW5116718
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Lot Number: KTP005908
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American