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

Model Number	024-269
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the lay user/patient contacted lifescan (lfs) usa, alleging a product usability issue with their one touch verio test strips.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 occurred at around 7:30 a.M., on (b)(6) 2025.The patient manages their diabetes with oral medication (metformin, 500 mg in the evening; farxiga, 5 mg daily and, glyburide, 5 mg twice daily).The patient advised that they woke up and ¿accidentally ingested some strips¿, approximately ¿7 to 10¿ test strips as they had confused the test strip vial with a medicine bottle.The patient advised that in response to ingesting the test strips, they attempted to vomit and ate a small piece of bread.The patient reported that they noticed that their ¿phlegm felt different ¿ not normal¿ and described having a ¿metallic and chemical¿ taste.The patient went to the emergency room at around 9 a.M., on (b)(6) 2025, where they received iv fluids, were placed on cardiac monitoring, had some lab samples taken and had a chest x-ray.The patient requested test strip information which the cca provided.This complaint is being reported because the patient reportedly received medical treatment from a healthcare professional after accidentally ingesting onetouch verio test strips.
Additional Manufacturer Narrative
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.In addition, a batch record review was performed on the subject test strip lot.The review did not identify anything that could adversely impact product performance or function.

• Brand Name: ONETOUCH VERIO
• 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: 23402955
• Report Number: 3008382007-2025-00020
• Device Sequence Number: 10039093
• Product Code: NBW
• UDI-Device Identifier: 00353885012614
• UDI-Public: 00353885012614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110637
• 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): 10/28/2025

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: 024-269
• Device Lot Number: 5882035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/28/2025
• 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