MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSORS; SENSOR, GLUCOSE, INVASIVE

Lot Number 0M0060X723R

Device Problem Low Readings (2460)

Patient Problem Hyperglycemia (1905)

Event Date 12/06/2019

Event Type  malfunction  

Event Description

I started using freestyle libre 14 day sensor.I use my readings to determine my insulin dose.The sensor started giving me low reading and i adjusted my medicines accordingly.After a few days, i decided to check with a different method.My reading were over 300 and the libre's reading was 133.This has caused me to go several days without taking my insulin to prevent me from going to low.To find out it wasn't accurate.This is very dangerous for people trying to control their blood sugar.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 9451601
• MDR Text Key: 170450076
• Report Number: MW5091579
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/16/2019
• Device Lot Number: 0M0060X723R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 MO
• Patient Weight: 150