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

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

Patient Problem Insufficient Information (4580)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

The freestyle libre 2 sensors are highly inaccurate, which could lead to in improper use of insulin, resulting in hospitalizations.One of our patients kept getting low readings on the libre.One of the times it read 59, when her finger stick read 122.There were other times when the libre read high (250) and her sugar was actually 134 upon finger stick.This error occurs on all different days throughout the 14 day sensor period.This should not be off this much and be allowed on the market.I have heard this complaint from multiple patients.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 2 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15192968
• MDR Text Key: 297686258
• Report Number: MW5111365
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/05/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1