MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	70914-70
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An error message was reported with the abbott diabetes care (adc) device.The customer received an unspecified error message on their meter display and was unable to obtain glucose readings.The customer experienced a seizure and a loss of consciousness and was able to self-treat with metformin which was provided to them by a healthcare professional.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An error message was reported with the abbott diabetes care (adc) device.The customer received an unspecified error message on their meter display and was unable to obtain glucose readings.The customer experienced a seizure and a loss of consciousness and was able to self-treat with metformin which was provided to them by a healthcare professional.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.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components 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.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, the product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle freedom lite meter and freestyle strip was reviewed and the dhrs showed the freestyle freedom lite meter and freestyle strip meet specifications prior to release to distribution.Retain testing was performed for freestyle strip and all units performed in specification and passed.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.This also serves as a correction report section h4 ( device mfg date) was incorrectly updated in the previous report.Correction has been made all pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE FREEDOM LITE
• Common Device Name: BLOOD 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: 20050318
• Report Number: 2954323-2024-32062
• Device Sequence Number: 7934097
• Product Code: NBW
• UDI-Device Identifier: 00699073714992
• UDI-Public: (01)00699073714992(10)01A020D(17)311221
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• 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): 01/16/2025

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: 05/31/2026
• Device Model Number: 70914-70
• Device Lot Number: 1230222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 01/12/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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: Male