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

Model Number	024-267
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194); Anxiety (2328); Syncope/Fainting (4411)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.An evaluation of the test strip lot was unable to be conducted as the lot number was not provided.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.Investigation concluded device performed as intended by displaying an error message and preventing the user from obtaining an erroneous result.
Event or Problem Description
On (b)(6) 2025, a lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verio flex meter was generating error 4 results.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call since the patient could not be reached to obtain additional information.The patient stated that the alleged issue began on the morning of (b)(6) 2024, and that they had been getting error 4 messages for 2 weeks.Ever since the first time he used 4 consecutive strips which generated error 4 results, the patient has been getting the error 4 message consistently.Since (b)(6) 2024, the patient had feelings of anxiety and on (b)(6) 2025, the patient felt dizzy, nauseous and fell unconscious.In response to the alleged issue, the customer did not take any action or receive treatment.The patient manages their diabetes with glipizide 5mg, at breakfast and at night.The cca noted that the test strips had been removed from their original vial and were being stored a pill container.Replacement products were sent to the patient.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly had an acute complication of diabetes, after the alleged meter issue began.Furthermore, the device could not be ruled out as a 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
• 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 ; 1463382112
• MDR Report Key: 21409073
• Report Number: 3008382007-2025-00003
• Device Sequence Number: 9311914
• Product Code: NBW
• UDI-Device Identifier: 00353885012485
• UDI-Public: 00353885012485
• 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): 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: 024-267
• Device Lot Number: Z2406036X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 02/19/2025
• Date Device Manufactured: 06/22/2024
• 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: Life Threatening
• Patient Sex: Unknown