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

Device Problems Compatibility Problem (2960); Problem with Software Installation (3013)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

Abbot did not supply up front information that iphone 14 is not compatible with the libre 3 sensor either on the container, in advertisement or in print.I had an iphone 6 and went to load the libre 3 app and found it was too old.It had a whole list of iphones that looked like 7 or greater.I bought an iphone 14.When i went to load the app, the libre 3 was not compatible with a 14.Called the consumer line as was informed that i and the provider should have read their on-line information before prescribing the product.That version of iphone has been available for 10 months.They suggested it by a reader, which is funny because there isn't a reader for the libre 3.I now have 1 sensor in my arm and 1 on my counter they i can't use.There needs to be some penalty.Reference report: mw5118041.

• Brand Name: LIBRE 3 SENSOR READER
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17050057
• MDR Text Key: 316503300
• Report Number: MW5118040
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: METFORMIN, PRAVASTATIN, ASPIRIN.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White