MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE

Model Number LIBRE 2

Device Problems Defective Component (2292); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

Switched to finger pricking; unable to test glucose level with the free style libre 2 cgm system due to sensor failure.Unfortunately this is a recurring problem with the free style libre 2 as sensor failure occurrences almost every other month, but this time 3 sensors failed one after the other following short use period from a few days to a few hours.The first 2 defective sensors returned to abbott for failure analysis the third defective sensor is in my possession.Abbott claim in their free style libre 2 user's manual page 4: "performance of the system when used with other implanted medical devices, such as pacemaker, has not been evaluated." abbott discontinue sending me replacement sensors for the defective ones, with the excuse that the free style libre 2 should not be used by people who have pacemaker.Since abbott didn't bother to perform any evaluation of the performance of the free style libre 2 system with people who have pacemaker, this excuse provides a perfect coverup for manufacturing defects of the free style 2 system.Fda safety report id# (b)(4).

• Brand Name: FREE STYLE LIBRE 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 13711138
• MDR Text Key: 287118239
• Report Number: MW5107964
• Device Sequence Number: 1
• Product Code: MDS
• 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: 03/06/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBRE 2
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male