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

Model Number FREESTYLE LIBRE 2

Device Problems False Alarm (1013); Defective Component (2292); Low Readings (2460)

Patient Problem Hyperglycemia (1905)

Event Date 06/01/2023

Event Type  malfunction  

Event Description

I attached abbott freestyle libre ii sensor on my left arm to monitor my glucose level.The sensor started giving very low readings and frequently alarms for low glucose.I measured the glucose using my strip.The sensor showed i have 54mg/dl.While the strip shows 210mg/dl.I compared readings for the next 3 days and the difference in readings continues.Abbott customer service is horrible and are trying to blame the user.I have been using these sensors for 8 months.This is my third time getting defective sensors.Either this device was not designed properly or there are severe quality problems.Internet is full of complaints from users.Unfortunately they are not aware of reporting it to fda.I recommend fda look at these complaints.

• Brand Name: ABBOTT FREE STYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 17080466
• MDR Text Key: 316811356
• Report Number: MW5118240
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FREESTYLE LIBRE 2
• Device Catalogue Number: 71926-01
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: 1000MG METFORMIN AND 1MG GLIMEPIRIDE.; MULTIVITAMINS, CALCIUM.
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: Asian