MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Patient of endocrine practice has been experiencing several error messages with freestyle libre 14 day sensor.He has contacted libre on several occasions and sent back to company sensors that were not working.I contacted libre support today and was advised that they do not know what error messages mean and that the only way to find out would be to send to company in california, only address listed no phone number.My patient has done that and continues to be without functioning sensor and now has worsening glycemic management.I bring this to your attention as it sounds absurd that a company does not know its own products error codes.I'm now pursuing a different sensor for this patient and will not recommend libre sensor again until this is resolved.Hopefully you can help them improve there troubleshooting management.Thank you for your time.Sincerely, (b)(6).Fda safety report id# (b)(4).

• Brand Name: ABBOTT FREESTYLE LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC. ; alameda CA 94502
• MDR Report Key: 12737938
• MDR Text Key: 279887624
• Report Number: MW5105065
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other