MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR KIT-14 DAY; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number KTP006062

Device Problems Delayed Alarm (1011); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2023

Event Type  malfunction  

Event Description

Wednesday pm started sensor and wait one hour to work, than alert to wait more than sixty minutes two times.Patient changed to new sensor and it worked fine.

• Brand Name: FREESTYLE LIBRE 2 SENSOR KIT-14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17172705
• MDR Text Key: 317646545
• Report Number: MW5118488
• Device Sequence Number: 1
• Product Code: PZE
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: KTP006062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female