MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problems Device Difficult to Setup or Prepare (1487); Low Readings (2460)

Patient Problem Hyperglycemia (1905)

Event Date 02/24/2023

Event Type  Injury  

Event Description

I use abbott freestyle libre 3 continuous blood glucose sensors to manage type 1 diabetes.I experienced a dangerous malfunction with a sensor over the past two days, which i reported to abbott today.I was dismayed by their anemic response and unwillingness to explain the malfunction.I have no confidence that they will investigate and correct the issue i experienced, as set forth below.I applied and scanned a new sensor on (b)(6) 2023 at approximately 4:00 pm.During the 60 minute warmup period for the sensor, the connected app on my iphone gave a message advising me to ensure the sensor was properly applied to my skin.It was.I scanned the sensor again, which initiated a second 60 minutes warmup period.This repeated one more time, and the third 60 minute warmup period concluded.The sensor thereafter reported blood glucose readings to the app as expected, and without further messages.Beginning on the evening of (b)(6) 2023, the sensor reported hypoglycemic readings of approximately 55 mg/dl.Although there were multiple such readings, the app's logbook function reports only one.Overnight, beginning at about 2:00 am, the app alarmed repeatedly, reporting persistent blood glucose readings of 55 mg/dl or lower.The app logbook inaccurately reports only some of these readings.I treated the hypoglycemia with carbohydrates and, ultimately, the sensor reported a significant increase in blood glucose, beginning at 10:00 am on (b)(6) 2023.This continued until approximately 1:30 pm, when the sensor and app reported that my blood glucose level again plummeted.I received alarm warnings on the app of dangerously low blood sugar--55 mg/dl or less each time--every half hour or so until approximately 1:00 am on (b)(6) 2023.Each time, i made treatment decisions, which included a significant volume of carbohydrates.At approximately, 1:00 am on (b)(6) 2023, i confirmed my blood glucose level by performing a finger stick reading with a glucometer.The reading was "hi", which corresponds to a blood glucose level of at least 400 mg/dl.This corresponds to severe hyperglycemia with the concurrent risk of ketoacidosis.I confirmed this reading with a new libre sensor.Had i not had suspicions about the accuracy of the initial libre sensor and app, life threatening ketoacidosis was only a matter of time.Fortunately, i was able to treat my hyperglycemia with insulin boluses.Some questions occurred to me as i thought about this today: why did the app not alert me that the sensor had malfunctioned and was unreliable; how is it possible that the sensor could be so inaccurate with it's readings; what if instead of errantly reporting hypoglycemia, the libre system instead errantly reported hyperglycemia? i would have treated this with fast acting insulin, repeated doses would have led to life threatening hypoglycemia; and what information can abbott provide to alleviate my concerns about life threatening inaccuracies without any error warnings? i called abbott today and was dismayed by their response.They took notes on the story i tell above.And they agreed to replace the sensor.And they asked that i return the sensor to them for analysis.But they would not tell me whether or not the issue i experienced is a known problem.They would not agree to follow up with me with an explanation.They would not provide contact information so that i could follow up with them.In summary, the freestyle libre 3 system should be able to self-detect and deactivate defective sensors to ensure that patients do not make treatment decisions based on woefully inaccurate blood glucose readings.Thank you for your consideration.This test result of approximately 55 mg/dl reflects multiple inaccurate reports received from the abbott freestyle libre 3 system on (b)(6) 2023.The accurate result of no less than 400 mg/dl was confirmed by a finger stick glucometer and a subsequent freestyle libre 3 sensor.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16461880
• MDR Text Key: 310642687
• Report Number: MW5115336
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE; ASPIRIN ; INSULIN ; ROSUVASTATIN; SYNTHROID; TADALAFIL; VITAMIN B COMPLEX; VITAMIN D3
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White