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

Model Number	024-369
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364); Syncope/Fainting (4411)
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.A device history record review was also performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.An evaluation of the test strip lot was unable to be conducted as the lot number was not provided.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.
Event or Problem Description
On (b)(6) 2025, the lay user/patient contacted lifescan (lfs) united states, the lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verio reflect meter was displaying error 2, 4 and 6 messages.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call.The patient reported that the alleged issue began at an unspecified date/time approximately one and a half weeks before the end of (b)(6) 2025.The patient manages their diabetes with self-adjusted insulin (lantus and humalog, doses not specified, taken daily) and the advised that in response to the alleged issue, they stopped administering their medication.The patient alleged that an unspecified time after the alleged issue(s) began, they ¿felt high glucose¿, that they ¿passed out and had diabetic ketoacidosis¿.The patient advised that they contacted emergency medical services (ems) who reportedly attended and subsequently administered ¿insulin drip, sodium, water and potassium¿.The customer was unable and/or unwilling to confirm if their blood glucose was measured at the time of ems arrival.At the time of troubleshooting, the cca established that the device was not being used for the first time.The patient was unwilling to walk through resolving the issue.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and reportedly required medical intervention from a healthcare professional after the alleged issues with the subject device occurred.

• Brand Name: ONETOUCH VERIO REFLECT
• 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: 22296367
• Report Number: 3008382007-2025-00011
• Device Sequence Number: 8892739
• Product Code: NBW
• UDI-Device Identifier: 00353885012959
• UDI-Public: 00353885012959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193475
• 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): 06/20/2025

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: 024-369
• Device Catalogue Number: 024-369
• Device Lot Number: K2406015X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 06/21/2024
• 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; Required Intervention
• Patient Sex: Unknown