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

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  Injury  

Event Description

Libre 2 insulin monitor failed within 10 mins of first use.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 LABS / ABBOTT DIABETES CARE INC.
• MDR Report Key: 12195877
• MDR Text Key: 262630210
• Report Number: MW5102622
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 136