MAUDE Adverse Event Report: ABBOTT LAB / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED,

Lot Number KTP004558

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2022

Event Type  malfunction  

Event Description

Freestyle libre 2 had a sensor error as i was having a low glucose event.It notified me initially as my glucose feel below 70, but failed to continue working.Error message received when scanning the device was "sensor error" and to rescan after 10 minutes.The device never came back online and i had to change out for a new sensor.The sensor was 12 days into its duty cycle.In general, this is a problem that has been encountered with every device that has been used.Use of the device has been for over 6 months now.Additionally, the device looses contact with the reader (usually an iphone) daily and therefore high and low glucose alarms are lost.Rescans do not always correct for lose of connection.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED,
• Manufacturer (Section D): ABBOTT LAB / ABBOTT DIABETES CARE INC.
• MDR Report Key: 16132169
• MDR Text Key: 307079882
• Report Number: MW5114242
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2023
• Device Lot Number: KTP004558
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL ; APIXABAN ; BACTRIM ; CENTRUM SILVER MEN; COMPOSINE; DOXYCYCLINE; FREESTYLE LIBRE 2; HUMALOG; IRON ; KCI; LANTUS; LEVOTHYROXINE; LINZESS ; METFORMIN ; MGCL ; PREGABALIN ; PROTONIX; TYLENOL ; TYLENOL PM; ZOFRAN
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic