MAUDE Adverse Event Report: ABBOT LABS / ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 2 CGM SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Free style libre 2 cgm sensors does not last the full 14 days as advertised.Fda safety report id # (b)(4).

• Brand Name: FREE STYLE LIBRE 2 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOT LABS / ABBOTT DIABETES CARE INC.
• MDR Report Key: 14874783
• MDR Text Key: 295229601
• Report Number: MW5110621
• 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: 06/28/2022

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 Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2022
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American