MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 14 DAY SENSOR AND READER; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number KTP003740

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

The abbott laboratories freestyle libre 2 - 14 day sensors are very poor quality and the battery life in the reader make it useless.Over the last year the sensor failure rate for me has been about 75% leaving me without glucose monitoring about 25% of the time.I have been using freestyle systems for about 3 years and all of this has happened in the last year so i know i am using the sensors correctly.I have contacted abbott customer support several times about this problem and they do send me new sensors to replace the faulty sensors, but due to paperwork and shipping delays i am sometimes without a sensor for about a week.The replacement sensors have the same failure rate, so ultimately, it does not matter that they are replaced or not because the replacement sensors have the same quality issues.This is a major problem with this sensor system and their quality issues need serious review and this product should not be approved because the poor quality has left me without glucose monitoring capability several times, sometimes up to a week.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 2 14 DAY SENSOR AND READER
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15799188
• MDR Text Key: 303747661
• Report Number: MW5113242
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Lot Number: KTP003740
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALENDRONATE SODIUM NA 70 MG 1/WEEK ; ASPIRIN 81 MG 1/DAY; CHLORTHALIDONE 12.5 MG MORNING ; CYCLOSPORINE 50 MG MORNING 75 MG NIGHT ; LOSARTAN; METFORMIN HCL 500 MG BID ; NOVALIN N 15 UNITS BID ; PANTOPRIZOLE SOD DR 40 MG MORNING ; POTASSIUM 50 MG BID ; PRAVASTATIN NA 40 MG BEDTIME; PREDNISONE 5 MG MORNING ; SIROLIMUS 0.5 MG MORNING
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White