MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71926-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Abbott diabetes care (adc) received a medwatch report which reported the following information: it was reported by the customer "i've been experiencing several problems with the freestyle libre 2 system.Specifically, the accuracy of the sensors/system is not close to what abbott labs is reporting their accuracy to be.Part of the quality/reliability/accuracy is traceable to the sensor devices themselves.Other problems are traceable to the freestyle libre 2 application that patients/consumers are instructed to install on their smart phone(s).Still other problems appear to be combined between the sensor devices and the app.First, the sensor i installed most recently has been providing wildly variable readings that generate false alarms of low blood glucose reading; by itself, this creates mistrust in the freestyle libre system causing patients to ignore the warnings when they should heed them (type 2 / beta error).My blood glucose tests using a meter and a drop of blood showed that the bg (blood glucose) reading was normal to slightly elevated when the freestyle libre 2 sensor was warning that bg was dangerously low.Second, the sensor would give highly variable readings taken in close succession; this is not possible when i, as the patient was not eating, had not eaten recently, and was not doing anything to highly affect actual blood glucose levels.Allowing abbott labs to continue advertising/publishing accuracy levels in marginal absolute relative difference (mard) of 7%-8% is misleading and fraudulent when the actual results are not proving to be consistent and the freestyle libre 2 systems is not providing an running calculation/estimate of mard as achieved.Since the instructions advise taking a blood glucose measurement using a bg meter regularly and if warnings are issued before treatment, manual entry of bg test results should permit/require an estimated mard for actual patient use.Third, the freestyle libre 2 sw (software) had several errors/problems: a) bluetooth connectivity is inconsistent and unreliable; b) signal loss errors are not accurately or correctly cleared after a signal loss warning; c) accuracy.Quality, and reliability of the results displayed is an issue; the sw app shows 100% in range when the system reported multiple out-of-range readings.If this is to be believed, then a warning that wakes a patient in the night should be more accurately reported and graphed; d) a recent ios update caused the freestyle libre app 2 to lose data and settings; after a deletion and reinstall of the app, the data loss and issues got worse.Abbott labs must comply with cybersecurity protections of pii/phi (personally identifiable information/protected health information) to avoid the freestyle libre app from being the mechanism of their own foreign customer service representatives stealing the pii/phi of us citizens and perpetrating fraud/theft on patients that use the freestyle libre 2 app/system; e) freestyle libre 2 should be updated to comply with all ios and android os updates within 72 hours of the release of these ios and os updates.Since most ios and os updates are complying with cybersecurity policy to mitigate vulnerabilities reported on the cybersecurity vulnerabilities and exposure (cve) website maintained by mitre for chs and cisa.When i called abbott labs to report these problems, i noted to them that they have failed to update their freestyle libre app to comply with cve patches or to mitigate risks as required.The croatian operator advised me to load an old ios version that contained cybersecurity vulnerabilities and instructed me to avoid updating ios versions until they instructed me to do so; this makes me and all other patients using the freestyle libre systems 2 & 3 vulnerable to identity theft and loss of pii/phi by abbott labs databases and centralized authorized and unauthorized reporting of our pii and phi.Please investigate abbott labs and their freestyle libre system/networks, and international support system for freestyle libre to identify and mitigate risks and vulnerabilities to this domestic medical care for us domestic patients.Upon going to sleep, test results seemed normal; 12:56 am was awakened from sleep by low glucose alarm warning; felt fine despite sensor warning of low glucose.Noted several readings that are out-of-character with reality, especially when compared to blood glucose meter readings/tests.Combines with a high number of signal loss alarms and erroneous readings, this system has a serious quality problem as well as potential hacking concerns by foreign customer service agents that should not be allowed access to us citizens' pii and phi.(b)(4), fcc id: qxs-lib02s".There was no report of any third-party intervention due to these issues.Adc customer service has contacted the customer and the customer reiterated their concerns from the medwatch report.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced a "communication error" with the sensor in use with the freestyle libre 2 application.Attempt to replicated customer complaint; however, per the abbott diabetes care compatibility guide for the freestyle libre 2 app, the reported configuration of ios 17.2.1.Is not compatible with the freestyle libre 2 app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18913649
• MDR Text Key: 337776804
• Report Number: 2954323-2024-09052
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599810009
• UDI-Public: 00357599810009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71926-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male