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

Model Number 71992

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

I'm not typing all this again! wait.I'm now doing it again because the picture file upload froze.I just experienced two back-to-back failures of abbott freestyle libre 2 sensors early this morning and as well as a failure on (b)(6) 2023, and one last fall.Lot ktp005922 sn (b)(6), lot ktp005922 sn (b)(6), and lot ktp005369 sn (b)(6).Reference reports: mw5116962, mw5116963, mw5116965.

• Brand Name: FREESTYLE LIBRE 2 SENSOR BLOOD GLUCOSE MONITOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 16807447
• MDR Text Key: 314073836
• Report Number: MW5116964
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 71992
• Device Catalogue Number: 71992-01
• Device Lot Number: KTP005922
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White