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

Model Number	023-270
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the spouse of a lay user/patient contacted lifescan (lfs) usa.The reporter alleged that the patient received an inaccurate high control solution result in addition to alleging that their onetouch verio flex meter was generating inaccurately high results compared to his feeling/normal results and compared to his continuous glucose monitor.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged issue began almost two months prior, at an unspecified date.On an unspecified date, the patient obtained a glucose reading of 249 mg/dl, which was considered unusually high for him compared to his feeling/normal results and within 2 minutes was compared to his dexcom continuous glucose monitor glucose reading of 110 mg/dl.In addition to this, the reporter alleged that on an unspecified date, the patient received an inaccurate high control solution result of 404mg/dl.The patient manages their diabetes with the following medication: lantus - 26 units, short-acting insulin 12 units before every meal, metformin two tablets of unspecified dosage.The patient did not make any changes to their medication in response to this issue.The reporter stated that approximately 6 weeks ago at about 1500, the patient was passing out and not responding.The reporter stated that she gave the patient candy, sugar, cookies and apple juice whilst also calling 911.Emergency personnel came to the reporter¿s home and gave the patient glucose.The cca noted that the test strips had been removed from their original vial and were being stored in the kitchen area.Otherwise, the patent¿s testing technique appeared appropriate.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event that required treatment from a health care professional and the device could not be ruled out as a cause and /or contributor to the alleged 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: 23299946
• Report Number: 2939301-2025-00034
• Device Sequence Number: 4890255
• Product Code: NBW
• UDI-Device Identifier: 00353885010979
• UDI-Public: 00353885010979
• 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): 10/15/2025

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: 01/31/2019
• Device Model Number: 023-270
• Device Catalogue Number: 023-270
• Device Lot Number: Z1707079X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• 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