MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONETOUCH VERIO FLEX; GLUCOSE MONITORING SYS/KIT

Model Number	024044
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	Hypoglycemia (1912); Syncope/Fainting (4411)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 27, 2025, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter would turn off during use and no longer turns on.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged power issue began 3 months ago.The patient manages their diabetes with oral medication (metformin 1000 mg) and insulin (novolog/dose unspecified).The reporter denied the patient made any changes to their usual diabetes management regimen as a result of the alleged issue.The reporter stated that on (b)(6) 2025, at 2:00 am, the patient became ¿unconscious¿ and was treated by emergency medical services (ems) with iv glucose and an unspecified injection.Prior to receiving treatment, the reporter claimed that the patient¿s blood glucose was measured on the ems meter and a result of ¿43 mg/dl¿ was obtained.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and that there was no indication of misuse of the device.The cca noted that the meter would not power on manually when the power button was pressed or when a test strip was inserted.The cca noted that based on the information provided, the battery did not needed replacing.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute complication of diabetes by a healthcare professional after the alleged power issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: ONETOUCH VERIO FLEX
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 23472441
• Report Number: 2939301-2025-00037
• Device Sequence Number: 16015615
• Product Code: NBW
• UDI-Device Identifier: 00353885011839
• UDI-Public: 00353885011839
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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 Model Number: 024044
• Device Catalogue Number: 024-044
• Device Lot Number: Z2406050X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown