MAUDE Adverse Event Report: ABBOTT ONE TOUCH FREESTYLE LIBRE GLUCOSE METER

Lot Number 171027U

Device Problems Defective Component (2292); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  Injury  

Event Description

The reporter stated she has had diabetes for over 70 years and her doctor gave her a new product to test her glucose but it does not work and should be taken off the market because it is dangerous.The libre comes in 3 separate pods.The applicator is in one pod and the sensor in another.You must twist off the top to attach them but the top does not twist off.Has called the company several times and was told that they know about it and have received several complaints.This should not have been approved and needs to be recalled.It is very unsafe when a diabetic cannot take her glucose to know what is going on.

• Brand Name: ONE TOUCH FREESTYLE LIBRE GLUCOSE METER
• Type of Device: GLUCOSE METER
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 7269545
• MDR Text Key: 100174220
• Report Number: MW5075219
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2018
• Device Lot Number: 171027U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR