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

Model Number	023-899
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoglycemia (1912); Presyncope (4410)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.In addition, 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.Also, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.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, alleging that their onetouch verio reflect meter was displaying an ¿error 2¿ (with sub-error code 2) message during testing.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged error message began to appear on (b)(6) 2025, and they were unable to measure their blood glucose levels.They did not take any action regarding their usual diabetes management as a result of the alleged issue.On (b)(6) 2025, after the alleged issue began, the patient claimed they developed symptoms of feeling ¿very weak and almost losing consciousness¿.Emergency medical services were contacted for assistance.When the paramedics arrived, they found the patient¿s blood glucose levels were ¿very low¿ (exact reading not provided).The patient stated that they were taken to hospital whey there received treatment of a dextrose tablet and unspecified medication.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time.The cca walked the patient though a test however the alleged issue could not be resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute complication of diabetes after they were unable to test their blood glucose due to the reported issue.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 22288608
• Report Number: 3008382007-2025-00010
• Device Sequence Number: 21063379
• Product Code: NBW
• UDI-Device Identifier: 00353885011716
• UDI-Public: 00353885011716
• 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): 06/18/2025

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 Expiration Date: 01/31/2023
• Device Model Number: 023-899
• Device Lot Number: K2107082X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 07/31/2021
• 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