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

Model Number	023-271
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Loss of consciousness (2418)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio meter would not turn on.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and additional information obtained when the medical surveillance specialist listened to the call recording.The patient could not be reached for follow-up.The patient reported that the alleged issue began at an unspecified date/time approximately 2 weeks prior to contacting lfs.The patient manages their diabetes with insulin (lantus insulin long acting 10 units per day and humalog, self-adjusted 8 ¿ 10 units 3 times per day) and they advised that they continued to administer their usual dose of medication in response to the alleged issue.The patient alleged that at an unspecified time after the alleged issue began, they ¿lost consciousness¿, which they attributed to not being able to obtain a glucose reading.The patient reported during the call that they called an ambulance and were taken to hospital where they received medical intervention as a result of the alleged issue; however, they were unable and/or unwilling to provide the specifics of the treatment allegedly received.At the time of troubleshooting, the cca established that the device was not being used for the first time.The cca confirmed that the patient was using the correct test strips; however, noted that the subject test strips had expired in february 2024.The cca noted that the meter did not power on when a test strip was inserted per owner¿s manual or when the power button was pressed.The cca verified the battery type required to operate the device, noting that the patient had installed the wrong type (crl2935 instead of the recommended type cr2032); based on this information, the meter¿s battery required replacing.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and reportedly required medical intervention after the alleged issue occurred.Furthermore, 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: 21863562
• Report Number: 2939301-2025-00015
• Device Sequence Number: 11910138
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• 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): 04/18/2025

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: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: Z2304014X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• 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; Hospitalization; Required Intervention
• Patient Sex: Unknown