MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Patient Problems Erythema (1840); Unspecified Infection (1930); Caustic/Chemical Burns (2549); Blister (4537)

Event Date 03/11/2024

Event Type  Injury  

Event Description

Patient called to report an adverse event from a freestyle libre 3 sensor.On (b)(6) 2024 she noticed 3 small blisters around the sensor.A couple hours passed by the blisters got bigger, were filled with fluid and she noticed "a big red ring around the blister".She went to urgent care thinking it was an allergic reaction but the physician informed her that is was not an allergic reaction it was a chemical burn.The patient had an infection and was prescribed silver sulfadiazine cream to apply twice a day for ten days and sulfamethoxazole-trimethoprim take one tablet twice a day for ten days.She did inform the manufacturer on march 12, 2024 of the adverse event.

• Brand Name: FREESTYLE LIBRE 3 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 18978241
• MDR Text Key: 338731031
• Report Number: MW5153136
• Device Sequence Number: 1
• Product Code: QLG
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: SILVER SULFADIAZINE.; SULFAMETHOXAZOLE-TRIMETHOPRIM.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female