MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14-DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hyperglycemia (1905)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

Patient ((b)(6) male with insulin-dependent type 2 diabetes) has been using freestyle libre 14-day sensors concurrently with dexcom g6 for 1 month - previously he was using only freestyle sensors.Freestyle libre readings were up to 50mg/dl or 35% off from dexcom readings.Dexcom readings appear to be most accurate based on patient's a1c (vs.Dexcom estimated a1c), office readings, and clinical data published.Alternatively, freestyle libre sensors do not appear to correlate to patient's bg readings or a1c, despite being used according to manufacturer labeling.In some cases, libre reported blood sugars <100mg/dl when patient's actual bg was 150mg/dl.This has caused the patient to struggle with self-monitoring and he now has little trust in any devices.He also does not trust his providers (endocrinologist, nurses, pharmacists, etc.) as they recommended these devices to him and to other patients despite these problems.Prior to starting the libre in (b)(6) 2020, his a1c was 8.2%.While on the libre, his a1c elevated to a highest recorded value of 10.2% (b)(6) 2020, and never returned to 8.2% or lower until after starting on the dexcom g6 in (b)(6) 2022.He has requested this report be filed with the fda for review of the freestyle libre 14-day system as "the squeaky wheel gets the grease".Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14-DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 13315170
• MDR Text Key: 284459383
• Report Number: MW5106851
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 57599-0001-01
• UDI-Public: 57599-0001-01
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEXCOM G6
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White