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

Model Number	024-237
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	11/20/2025
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.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.Similar complaints for this issue were also 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.In addition, lifescan conducted a strip lot evaluation and concluded that the complaints associated with this lot do not require escalation and no systemic issue was observed.Investigation has not confirmed that a device malfunction has occurred.
Event or Problem Description
On (b)(6) 2026, the lay user/patient contacted lifescan (lfs) usa alleging that their onetouch verio reflect meter was reading inaccurately erratic.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call and additional information obtained by review of the call by a medical surveillance specialist.The alleged issue began on (b)(6) 2025.The patient reported receiving readings of "132mg/dl" and "167mg/dl" with less than 20 minutes between results with the subject device.The patient also reported receiving consistently high readings compared to her feelings and dexcom g6 sensor.The patient manages their diabetes using an insulin pod which delivers one-third of a unit of insulin per hour.As a result of the alleged issue, the patient increased their dose of medication (increased dose unknown).After 3pm on (b)(6) 2025, the patient became unconscious.Emergency services measured the patient's blood glucose using their meter which revealed the patient's blood glucose was "low".Emergency services treated the patient with iv dextrose.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly and an approved sample site was used for testing.The cca attempted to guide the patient through a test with control solution, but the patient did not have control solution.Replacement products were sent to the patient.This complaint is being reported as an adverse event for the following reasons: the patient developed signs/symptoms suggestive of a serious injury and received medical treatment due to a severe blood glucose excursion after increasing medication based on the elevated readings obtained with the subject meter.

• 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 ; 1463383679
• MDR Report Key: 24618088
• Report Number: 3008382007-2026-00004
• Device Sequence Number: 9841564
• Product Code: NBW
• UDI-Device Identifier: 00353885012430
• UDI-Public: 00353885012430
• 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): 03/17/2026

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: 024-237
• Device Catalogue Number: 024-237
• Device Lot Number: K2412008X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2026
• Initial Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 12/06/2024
• 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: Required Intervention; Life Threatening
• Patient Sex: Female