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

Lot Number 200805P

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Blister (4537); Reaction to Medicinal Component of Device (4574)

Event Date 10/09/2020

Event Type  Injury  

Event Description

Had a abbott freestyle libra sensor applied to my upper arm.The adhesive caused a allergic reaction to my skin, caused itching and blistering in the adhesive ring.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRA 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10733208
• MDR Text Key: 213253351
• Report Number: MW5097433
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2021
• Device Lot Number: 200805P
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 117