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

Lot Number 6265365

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/28/2021

Event Type  Injury  

Event Description

Swing in glucose levels; i received an order from (b)(6) approximately three months ago for a 90 day supply of the abbott libre freestyle 2 continuous glucose monitoring (cgm) sensors and device. This was a total of 7 sensors (14-day sensors) and the sensor reader. The 3rd sensor that i used was giving vastly varying readings with ranges as much as 70 points different from finger stick readings setting off the reader's alarms for low blood sugar. When the alarm sounded each time, i checked my glucose with a finger stick to decide on treatment because i did not feel that my glucose was low as i am consciously aware of hypoglycemic incidents when they occur. One alarm result showed my glucose was 47 when the finger stick indicated it was 117. Another alarm indicated 59 and the finger stick indicated 108. A third indicated hyperglycemia of 174 when the finger stick indicated 121. I removed the sensor after the last reading and replaced it as these three readings all occurred during a 12-hour window. I was not aware that i should have contacted abbott direct with issues until i contacted the distributor later because i was going to be one sensor short to finish my 90 day supply. On may 28, the sensor worked fine during the morning. Shortly before lunchtime, the sensor stopped working when i attempted to check it the reader indicated to recheck in 10 mins due to an issue. I repeated this process over the next 4 hours getting the same message. I checked the reader using its self-analyzing test and it indicated twice the reader was working properly. I then contacted abbott directly because i was only on the 8th day of use with the 14-day sensor. The tech at abbott talked me through the same self-test i had already performed then had me read off the event codes to him which had approximately 8 fault code incidents for the sensor with multiple code numbers. He then told me that the sensor had failed and needed to be replaced. This was the second sensor out of 7 which indicated an almost 29% failure rate for these sensors. I had the sensor control code for the second sensor failure because i started keeping the packaging after the first failure. I provide the tech with the control/serial number of the failed sensor. He said they would ship another but because of the memorial day holiday, it would not arrive until at least tuesday so i was going to be without this monitoring for approximately five days. I think a 29% failure rate is extremely high and i do not know if both sensors were in the same manufacturing batch or if this was just a coincidence but the libre 2 is the newer of the freestyle libre line of products as it still does not have a cell phone app approved by the fda for cell phones. I am waiting on additional sensors from abbott and the insurance company distributor, but i am now going to be overly cautious about this product and my incidents should be looked at as part of any other complaints about these sensors. Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 2 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11929711
• MDR Text Key: 254278745
• Report Number: MW5101671
• Device Sequence Number: 2
• Product Code: MDS
• 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: 05/29/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 6265365
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 06/02/2021 Patient Sequence Number: 1