MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Patient Problems Rash (2033); Blister (4537)

Event Date 09/29/2023

Event Type  Injury  

Event Description

I've had 2 events now where the adhesive on my abbott freestyle libre 3 has caused a blistering rash under the device that is discovered upon removal.I've used the product for years without issue.In addition, this new adhesive is not as sticky, which has resulted in 2 devices coming off earlier than they should.Reference reports mw5146811, mw5146813, mw5146814.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17920435
• MDR Text Key: 325817816
• Report Number: MW5146812
• Device Sequence Number: 1
• Product Code: QLG
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CYMBALTA.; CRESTOR.; MONTELUKAST.; XYZAL.
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White