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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2021

Event Type  malfunction  

Event Description

Freestyle libre 14 day sensor.Dates my last 4 sensors failed; (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: FREESTLYE LIBRE 14 DAY GLUCOSE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12513132
• MDR Text Key: 273091517
• Report Number: MW5104134
• Device Sequence Number: 2
• Product Code: MDS
• 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: 09/19/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 127