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

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2024
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.
Event or Problem Description
On december 20, 2024, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter read inaccurately low compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation, since contact information for the patient was not provided to obtain further information.It was not reported when the alleged meter inaccuracy began.No specific readings were provided.It was not reported if the patient takes medication to manage their diabetes or if they made any changes to their usual diabetes management regimen in response to the alleged issue.It was not reported if the patient developed any symptoms, however, the reporter mentioned that at an unspecified date and time the emergency medical services (ems) were notified for assistance since the result on the subject meter was ¿too low¿.When ems arrived, the reporter indicated that the patient received a blood glucose test and unspecified treatment.The reporter declined to provide further information.The reporter declined to complete the troubleshooting process.This complaint is being reported because the patient reportedly required medical intervention for a possible acute complication of diabetes while using the product.There is insufficient information to rule out the contribution of the subject meter 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
• 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: 21108196
• Report Number: 3008382007-2025-00001
• Device Sequence Number: 15649164
• 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): 01/08/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown