MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD LIBRE 3 APP FREESTYLE; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	71926-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Application Program Problem (2880)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.At this time product has not yet been returned and a valid serial number has not been provided.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and the investigation concluded that the tripped trend was not correlated with a product nonconformance.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.H10 was incorrectly documented in the previous mdr submission.H11 has been updated to reflect correct investigation activities.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem 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: LIBRE 3 APP FREESTYLE
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney CA 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18864460
• Report Number: 2954323-2024-08057
• Device Sequence Number: 3089125
• Product Code: QBJ
• UDI-Device Identifier: 00357599810009
• UDI-Public: 00357599810009
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K223435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 71926-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 05/15/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/28/2024; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown