MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE2 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Model Number (10)KTP008291

Patient Problem Insufficient Information (4580)

Event Date 03/31/2024

Event Type  malfunction  

Event Description

Freestyle libre2 failed to work.

• Brand Name: FREESTYLE LIBRE2 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 19033478
• MDR Text Key: 339384327
• Report Number: MW5153509
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000
• 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: 03/31/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: (10)KTP008291
• Device Catalogue Number: 240930 (17)
• Device Lot Number: (91)71992-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White