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

Lot Number T60001030

Device Problems Application Program Version or Upgrade Problem (2881); Device-Device Incompatibility (2919); Activation Problem (4042)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Reporter called to submit a report about the problem he encountered when he was trying to use freestyle libre 3 sensors app with his phone.The reporter stated that his physician prescribed this device and was filled by (b)(6).He said the way it works is, the sensor that is worn on the back of the upper arm supposed to download from an app which is paired with your phone.By doing that it continuously measures your blood glucose.However, it only works with the phone operating system version 10, 11 and 12.Since his operating system is version 9, the app is not working with his phone.He said there is no information on the internet, nor in the box that says the app is designed to work with the latest versions only.Another option he had was to buy a reader, however the freestyle libre 3 reader is not in stock.He is left with a device that he is not able to use, and they refused to refund his money.He said he reached out to the corporate office of abbott and spoke with a supervisor.He said he was told that they are working on it.He said he also spoke with fda representative in another state and was given a claim #(b)(4).

• Brand Name: FREESTYLE LIBRE 3 APP
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17267705
• MDR Text Key: 318564602
• Report Number: MW5119117
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Device Lot Number: T60001030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 107 KG