MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

I have attempted to use the abbott labs freestyle libre 2 gsm and have had 5 out of 5 sensor failures.I placed the first sensor correctly and had it work for the entire 14-day life cycle.After replacement of 5 failed sensors and 1 reader, how could the freestyle libre 2 system be considered effective with a 100% sensor failure rate? the sensor failures happen within the first hour of initialization between the reader and the sensor.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14592448
• MDR Text Key: 293341689
• Report Number: MW5110065
• Device Sequence Number: 1
• Product Code: NBW
• 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: 05/31/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Patient Sequence Number: 1
• Treatment: LISINOPRIL - 20 MG PER DAY; VITAMIN D3 - 5000 UNITS PER DAY
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White