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

Device Problems Loss of or Failure to Bond (1068); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2023

Event Type  malfunction  

Event Description

One sensor did not stay in his arm.Two sensors have given faulty readings as much as 122 points above fingerstick blood sugar level, considering how expensive they are and how crucially important it is to give the right amount of insulin i was quite disappointed.I can be reached at (b)(6) for additional information.I've had one sensor that didn't stay in and 2 that were giving false readings.Considering how expensive they are i am very disappointed.It was over a hundred point higher than the finger stick.Thank you (b)(6).Reference report: mw5118784, mw5118785.

• Brand Name: FREE STYLE 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: 17199603
• MDR Text Key: 317948938
• Report Number: MW5118786
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White