MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 3 SENSOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number 0ATRJ8UUF

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Application Program Problem (2880); Device Sensing Problem (2917); Activation Failure (3270)

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

Event Date 02/13/2023

Event Type  Injury  

Event Description

I purchased two libre 3 sensors to monitor my blood sugar as i was starting on insulin.Because i don't inject insulin 3 times per day, i had to pay out of pocket for the sensors.The first one consistently gave me inaccurate readings (up to 100 pts off) when i checked against my usual readings from finger sticks.The second sensor wouldn't work at all and kept sending a message to the app that it wasn't on my arm correctly when it was.I called abbott today and talked to customer service.After a lengthy call they said they would send new sensors in the mail, taking up to 10 business days because i could test my blood the old fashioned way.But lows occur at night and unless i stayed up all night to test my blood i would never know if i had a low and could die without the sensor.They could not get it through their heads or protocol that being able to test with a finger stick is not sufficient if you are on insulin.I asked them to fedex the new sensors and they refused.I believe they have a run of faulty sensors and i can't keep shelling out money for sensors that don't work.Reference report: mw5116002.

• Brand Name: FREESTYLE LIBRE 3 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 16627212
• MDR Text Key: 312166421
• Report Number: MW5116001
• Device Sequence Number: 1
• Product Code: PZE
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2023
• Device Lot Number: 0ATRJ8UUF
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White