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

Model Number (91)71940-01

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Irritation (2076); Urticaria (2278)

Event Date 04/21/2020

Event Type  Injury  

Event Description

Hives; the last two freestyle libre sensors that i attached to my arms left raised red itchy circles of irritation on my arms that have not gone away.It appears to be an allergic reaction to the adhesive of the sensors.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10009224
• MDR Text Key: 189496471
• Report Number: MW5094307
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00357599001018
• UDI-Public: (01)00357599001018
• 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: 04/27/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: (91)71940-01
• Device Catalogue Number: 71940
• Device Lot Number: 191124R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 86