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

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/22/2021

Event Type  malfunction  

Event Description

Causes wrong doses of insulin; sensor and monitor worked for 24 hours and stopped working.Monitor malfunctioned and wouldn't read after 24 hours.Plus alarm went off constantly prior to the 24 hours.I filed a separate complaint regarding my device that is the same.Both sensor and device was working.We got 3 readings before it stopped.Device said to replace sensor.Sensor is supposed to work for 14 days before replacing.When i searched the intranet, i saw many bad reviews on this product.Not sure why this agency hasn't stepped in already.Elderly are having to pay out of pocket in some cases and they are on fixed incomes.Something needs to be done.I hope you log a full investigation.Also read the comments from consumers.Abbott needs to be stopped until all issues are rectified.They can't possibly expect consumers, who are relying on these devices and sensors to check blood sugar levels several times a day, call abbott for replacements sensors and/or devices.That's ridiculous! and you are the only agency that can stop this from happening.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12066815
• MDR Text Key: 259365699
• Report Number: MW5102145
• Device Sequence Number: 1
• Product Code: PZE
• 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: 06/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 82