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

Lot Number T60000609

Device Problems Nonstandard Device (1420); Low Readings (2460)

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

My freestyle libre-3 cgm (continuous glucose monitor) sensor alarmed me 3 times of a low glucose problem with readings of 53, 53, 52.A fingerstick test said that the blood glucose level was 116.The cgm reading caused me to eat extra candy to bring my sugar level up.Abbott labs (the maker of the freestyle libre-3) said that my sensor had expired 24 days ago and they could not replace the sensor.There should be a warning when the sensors are out of date or should not function.Abbott was unwilling to replace the sensors.

• Brand Name: FREESTYLE LIBRE 3 CGM SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17228600
• MDR Text Key: 318292892
• Report Number: MW5118968
• 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: 06/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Lot Number: T60000609
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: METAMUCIL.; 81MG ASPIRIN.; CALCIUM.; LANTUS INSULIN.; METFORMIN.; MULTI-VITAMIN.; SIMVASTATIN.; VITAFUSION.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian