MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3 PLUS; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Experiencing low glucose readings - 10-20 point below what i find with a manual finger-stick check.This has been happening since i started the monitor 9 days ago.Since the gap was decreasing and i thought it was getting better, so continued to use, but gap has widened again.Readings are consistently inaccurate.Need replacement and to get back on track with more reliable recording/reporting.

• Brand Name: FREESTYLE LIBRE 3 PLUS
• Common Device Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 24701665
• Report Number: MW5185955
• Device Sequence Number: 17583314
• Product Code: QBJ
• UDI-Device Identifier: 00357599841003
• UDI-Public: (01)00357599841003(8012)1.2.1.1856.3
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMLODOPINE ; METFORMIN
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: Black Or African American