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

Lot Number 220812Q

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

I'm a new user of the freestyle libre 14 day continuous glucose monitoring.My first sensors worked for 14 days without problem.Since that time, i have had 3 bad/failed sensors in a row.They keep sending replacement sensors that fail.I have lost faith in their equipment and asked for the cost of my last months sensors to be refunded, (b)(6).The last sensor on day 3, not the first 24 hours, averaged about 50 points high.This kind of misinformation can't be used to manage blood glucose.I don't understand how a company can sell a product that doesn't work and doesn't have to make refunds.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15916450
• MDR Text Key: 304920894
• Report Number: MW5113622
• Device Sequence Number: 2
• Product Code: PZE
• UDI-Device Identifier: 003575599001018
• UDI-Public: (01)003575599001018
• 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: 11/30/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Lot Number: 220812Q
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White