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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Scarring (2061); Reaction (2414); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 08/12/2020

Event Type  Injury  

Event Description

Severe rash and scarring; have had several moderate to severe localized reactions to the adhesive use on the freestyle libre cgm sensor.These include redness, weeping skin, severe itching and persistent red mark left after 45 days in multiple locations.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE US 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10501348
• MDR Text Key: 206145609
• Report Number: MW5096453
• Device Sequence Number: 1
• Product Code: MDS
• 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: 09/03/2020

1 Device was Involved in the Event

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 110