MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE FLASH GLUCOSE MONITORING SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Fluid Discharge (2686); No Code Available (3191)

Event Date 03/15/2019

Event Type  Injury  

Event Description

Reaction to adhesive on freestyle libre sensor including itching, blistering and seeping.Has been happening since approx (b)(6) 2018.Use of barrier sprays or wipes as recommended by mfg has no effect.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE FLASH GLUCOSE MONITORING SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 8522690
• MDR Text Key: 142262275
• Report Number: MW5085911
• Device Sequence Number: 1
• Product Code: MDS
• 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: 04/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B12; CRESTOR; FREESTYLE CGM; INSULIN ; LEVOTHYROXINE ; LISINOPRIL; METFORMIN ; MULTIVITAMIN ; OMEGA3
• Patient Age: 67 YR
• Patient Weight: 132