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

Device Problem Electromagnetic Interference (1194)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Event Description

I wear a libre 3 sensor for diabetes.I was in a procedure room at work and we were using fluro/x-ray.My sensor stopped working as soon as fluro/x-ray was started.I did everything the manufacture suggested to get the sensor to work and it didn't work.I replaced the sensor once my prescription came in and i was able to get my readings with a new sensor.

• Brand Name: LIBRE 3 FREESTYLE SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16015147
• MDR Text Key: 305819825
• Report Number: MW5113853
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: HUMALOG, LANTUS, X-RAY.
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White