MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 2 SENSORS; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Device Problems Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problem Hyperglycemia (1905)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Free style libre 2 devices i tried to use for 2 years from 2020 to 2022 did help initially to maintain my blood sugar by knowledge of my sugar; however the devices functioned worse and worse over time and the cost increased dramatically with medicare coverage to the point i could no longer use them.The devices fell off, would not even stick on as previously, despite my having been trained how to use them and successful use of them before.My blood sugars increased dramatically and my hba1c increased from 8.-% to 12.3% which my doctor feels is a significant adverse effect.

• Brand Name: FREE STYLE LIBRE 2 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16386376
• MDR Text Key: 309759311
• Report Number: MW5114978
• Device Sequence Number: 1
• Product Code: PZE
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LEVEMIR INSULIN; MELALEUCA VITAMINS; NOVOLOG INSULIN; PREGABALIN; TELMISARTAN
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White