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

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Recall on device.They will not replace.Device on recall.Called 3 times.They will not replace it.Free style libre 2.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 17058963
• MDR Text Key: 316625420
• Report Number: MW5118122
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• 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: TERCIBA, GLYBURIDE, TOO MANY TO LIST.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White