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

Model Number	72077-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Software investigation: an investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported signal loss.With freestyle libre 3 application.Per the compatibility guide, use of the iphone 11, ios 18.1 is incompatible with the freestyle libre 3 application.This guide is available to the user on the websites where the product is launched.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.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.Sensor investigation: an investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.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.If product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone 11 with ios operating system version 18.1.The customer received a signal loss and was not alerted of changes in glucose level.As a result, the customer experienced symptoms described as "lack of control", dizziness, sweating and was unable to self-treat.The customer was treated with glucagon spray by a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful.The sensor was activated with a known good reader and signal and sound icons were observed as activated.Waited few minutes to ensure that there was no disruption in the bluetooth connection between the devices.Reader was connected to software and isf (interstitial fluid) command was sent.First 5 ble (bluetooth low energy) packets were received successfully.The blc count and rssi (received signal strength indicator) were present for all packets.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone 11 with ios operating system version 18.1and app version 3.6.1.11430.The customer received a signal loss and was not alerted of changes in glucose level.As a result, the customer experienced symptoms described as "lack of control", dizziness, sweating and was unable to self-treat.The customer was treated with glucagon spray by a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 20888552
• Report Number: 2954323-2024-48054
• Device Sequence Number: 7842935
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

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 Expiration Date: 02/28/2025
• Device Model Number: 72077-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2024
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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: Required Intervention
• Patient Sex: Unknown