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

Model Number 71926-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problem Convulsion/Seizure (4406)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported a replace sensor error message on app screen.The reported issue was investigated and attempted to be replicated.Per the abbott diabetes care compatibility guide for the freestyle libre 2 app art41556-202, 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.There were no issues identified with the freestyle libre 2 app during replication that would have led to the reported issue.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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.

Event Description

A "replace sensor" error message was reported with the abbott diabetes care (adc) device using the freestyle libre 2 application on the customer¿s iphone 13 with ios operating system version 17.2.1 and the customer was unable to obtain readings.The customer experienced seizure, and no third-party treatment was reported.No further details were provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint.The customer reported an error message on app screen.The reported issue was investigated and attempted to replicate.The reported configuration was not compatible with the freestyle libre 3 app.The latest revision of the compatibility guide was 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.This serves as a correction report.Section d1 (brand name) and h10 (addtl mfg narrative) were incorrectly documented in the initial report.The correction has been made here.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A "replace sensor" error message was reported with the abbott diabetes care (adc) device in use with iphone 13, os 17.2.1, app version 3.5.0.8863 and the customer was unable to obtain readings.The customer experienced seizure, and no third-party treatment was reported.No further details were provided.There was no report of death or permanent impairment associated with this event.

• 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: 18864460
• MDR Text Key: 337185156
• Report Number: 2954323-2024-08057
• 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: K223435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other