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

Model Number	023-271
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 26, 2026, the lay user/patient¿s spouse contacted lifescan (lfs) united states, alleging that that the patient¿s onetouch verio flex meter was displaying an ¿error 2¿ message during testing.The complaint was classified based on the customer care agent (cca) documentation, since attempts to reach the reporter for further information were unsuccessful.The reporter stated that on february 25, 2026, at 1:30 am, the patient was sleeping and when she attempted to wake him, he was ¿unresponsive¿, and an ¿error 2¿ message appeared when attempting to test his blood glucose with the subject meter.The reporter stated that she called emergency medical services (ems) for assistance.When ems arrived, the reporter claimed that they tested the patient¿s blood glucose on the ems meter (unspecified result) and provided unspecified treatment.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca walked through resolving the issue however the alleged issue could not be resolved.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for a possible acute complication of diabetes after the alleged meter issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.In addition, similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.The reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.

• Brand Name: ONETOUCH VERIO FLEX
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 24662923
• Report Number: 3008382007-2026-00005
• Device Sequence Number: 20097460
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: Z2308021X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/23/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male