MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR; FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSULIN DELIVERY SYSTEMS

Device Problem Defective Device (2588)

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

Event Date 02/20/2023

Event Type  Injury  

Event Description

Freestyle libre 2 sensor failed 4 days before expected date.I'm on a cruise with no way to acquire a replacement sensor.There is no way to reactivate the failed sensor.

• Brand Name: FREESTYLE LIBRE 2 SENSOR
• Type of Device: FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSULIN DELIVERY SYSTEMS
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16445602
• MDR Text Key: 310361779
• Report Number: MW5115224
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HUMALOG; JARDIANCE; TOUJEO; TRULICITY
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White