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

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Abbott's freestyle libre 14 day and freestyle libre 2 sensors have been dispensed incorrectly by pharmacies due to nearly identical packaging.Each of these sensors only work with their approved reader and cannot be used interchangeably.Reporter's recommendations the packaging looks nearly identical.Many health care practitioners are not aware of the difference between the freestyle libre 14 day and freestyle libre 2 and how they are not interchangeable.They are both 14 day use but the freestyle libre also has alarms as an added feature.The manufacturer should consider different colors on the packaging to make it more obvious to dispensing pharmacists.They could also consider renaming the products to make it easier to distinguish.(b)(6).Submission id (b)(4).

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12634001
• MDR Text Key: 276881617
• Report Number: MW5104622
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/11/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1