MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2 SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hyperglycemia (1905)

Event Date 11/27/2021

Event Type  Injury  

Event Description

This is a representative date, there have been many others, where the sensor reading on occasion has been off by almost 90 points from the test strip.The first time this occurred, the device set off an alarm for low blood sugar in the range of approx 50s.I was unaware of the difference and as recommended for hypoglycemia, i took glucose tablets and tested until the levels were around 100.But on a hunch i decided to test myself with my original meter (onetouch verio) and discovered a difference of 100+ points.My blood glucose levels rose to around 260+ that day.From then on i began recording the difference.I contacted abbott.They sent me 3 new sensors.But all of them continued to have large differences between the sensor and the meter unpredictably.Abbott sent me a return kit for returning the defective sensors, so i don't have them any longer, but i do still have the meter.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 2 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 13061407
• MDR Text Key: 282774783
• Report Number: MW5106219
• Device Sequence Number: 1
• Product Code: MDS
• 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: 12/18/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; CENTRUM SILVER; COQ-10; GUNFACINE ; HUMULIN ; LAMOTRIGINE; METFORMIN ; PLAVIX ; PROTONIX ; VITAMIN B12; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian