MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. LIBRE3; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR US

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Unspecified Infection (1930)

Event Date 06/05/2023

Event Type  Injury  

Event Description

My libre3 caused a serious infection.Due to the installation of the device, the infection was not noticeable until the device was removed after it stopped reading my glucose levels correctly.

• Brand Name: LIBRE3
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR US
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17163704
• MDR Text Key: 317732795
• Report Number: MW5118474
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 101 KG