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

Model Number 70805-70

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Blurred Vision (2137); Dizziness (2194)

Event Date 08/04/2023

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.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle lite were reviewed and the dhrs showed the freestyle lite passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported encountering an "error-4" message upon pressing the button on their abbott diabetes care (adc) device.The customer experienced symptoms described as "difficulty walking, half of the left eye vision is obscure, a stroke" and dizziness.The customer was taken to the hospital and was provided with intravenous glucose by the healthcare professional for hyperglycemia diagnosis.Additionally, the customer had a brain scan, stroke therapy, and was provided metoprolol, clavix, aspirin, and metformin for treatment.No further information was reported.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LITE
• Type of Device: 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: 18961867
• MDR Text Key: 338386824
• Report Number: 2954323-2024-09814
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073708052
• UDI-Public: (01)00699073708052(10)02B352D(17)260731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092602
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70805-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American