MAUDE Adverse Event Report: LifeScan Europe GMBH OneTouch Verio Flex; Glucose Monitoring Sys/Kit

Model Number	024044
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/26/2026
Type of Reportable Event	Serious Injury

• 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: 50926758
• Report Number: 3042301847-2026-00039
• Device Sequence Number: 18575458
• 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): 09/28/2026
• Report Date (Section F): 09/28/2026

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: Z2407053X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• 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: Life Threatening
• Patient Sex: Unknown