MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSORS; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Lot Number KTP006887

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/09/2023

Event Type  Injury  

Event Description

Last 3 sensors have failed after being on arm.Has not been able to check "bs".Does not have a test strips to monitor at home.Ref report: mw5146943, mw5146944.

• Brand Name: FREESTYLE LIBRE 2 SENSORS
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17939161
• MDR Text Key: 325806988
• Report Number: MW5146942
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: KTP006887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic