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

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/06/2022

Event Type  Injury  

Event Description

I've been using the abbott freestyle libre 14 day continuous glucose monitoring system since (b)(6) 2021.I've had multiple sensors fail on day 1 of use or premature failures well before the planned 14-day period of use.The rate of sensor failure is 50%.I am a physician who happens to use this device.It is extremely unlikely that this is a user error.Error codes on day 1 are "your sensor is not working.Please remove your sensor and start a new one." i've also had improbably low blood sugar readings followed by error messages indicating sensor failure.I have serious concerns regarding the quality/reliability of this essential device.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 14074505
• MDR Text Key: 289092820
• Report Number: MW5108870
• Device Sequence Number: 1
• Product Code: MDS
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male