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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943)

Event Date 11/28/2018

Event Type  Injury  

Event Description

My son's freestyle libre sensor came off early and where it had been on back of his upper arm as recommended, was highly inflamed - raw.Still red at the present time.He had been suffering a terrible itch also with it on.Started him on an antihistamine tablet to counteract the itch.The redness has been ongoing for a long time for him.

• Brand Name: ABBOTT FREESTYLE LIBRE
• Type of Device: SENSOR GLUCOSE INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8129172
• MDR Text Key: 129432321
• Report Number: MW5081815
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/30/2018

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR