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

Device Problems Low Readings (2460); Device Sensing Problem (2917)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The freestyle libre 3 has failed the last 4 sensors i have applied.It reported normal levels the first day and then reported low glucose readings such as 53 when my finger stick was 123.Each one lasted 4-5 days and then i was informed that the sensor no longer worked.An error code of 365 was given on each sensor.I reported it to the company and they sent me a replacement but they are supposed to last 14 days.I used the libre 2 also and had 8 out of 10 stop working early and give false hypoglycemic events.The failure rate is too high and it caused me to eat more carbs, and have high glucose levels that were not being recorded by the sensors.Reference reports mw5116380, mw5116382, mw5116383.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16689453
• MDR Text Key: 312936093
• Report Number: MW5116381
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BUPRENORPHINE; CALCIUM; CITALOPRAM; DEXILANT; DOCUSATE; DRONABINOL ; ESTRADIOL ; FAMOTIDINE; FEXOFENADINE; IRON ; LEVOTHYROXINE; LIOTHYHRONINE; LISINOPRIL ; METFORMIN ; METOCLOPRAMIDE; ORPHENADRINE; PIOGLITAZONE; ROSUVASTATIN ; SENNA; TRULICITY; VITAMIN B; VITAMIN D; ZOLPIDEM
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White