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

Model Number	024044
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194)
Date of Event	01/15/2025
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 his onetouch verio flex meter read inaccurately low compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation, and on additional information obtained by the medical surveillance specialist after reviewing the call recording.The patient reported that on (b)(6) 2025, at around 3:30 pm, he began feeling ¿lightheaded and dizzy¿.The patient claimed he tested his blood glucose with the subject meter at around 4:00 pm and obtained an alleged inaccurate low blood glucose reading of ¿300 mg/dl¿.The patient stated that he proceeded to the emergency room (er) where he received a blood glucose result of ¿500 mg/dl¿ on the er meter at around 4:30 pm and received unspecified treatment intravenously and 1 pill of metformin 500 mg.At the time of troubleshooting, the cca determined that the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after the alleged inaccuracy 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: 21411310
• Report Number: 2939301-2025-00007
• Device Sequence Number: 12815622
• Product Code: NBW
• UDI-Device Identifier: 20353885011833
• UDI-Public: 20353885011833
• 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): 02/19/2025

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: Z2401058X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• 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: Required Intervention
• Patient Sex: Unknown