MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONETOUCH ULTRA2; GLUCOSE MONITORING SYS/KIT

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dizziness (2194); Syncope/Fainting (4411)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra 2 meter was reading inaccurately high compared to their feelings and compared to another unknown meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and based on additional information obtained from listening to the call recording by a customer quality specialist.The patient reported that the alleged issue began at 4:00 pm on the (b)(6) 2024.The patient claimed obtaining a blood glucose reading of ¿195 mg/dl¿ with the subject device which they felt was inaccurately high compared to their feelings and also compared to a blood glucose reading of ¿10 mg/dl¿ with an unknown emergency medical services (ems) meter.The patient does not have any diabetes medications and manages their diabetes with diet and exercise only.The patient denied making any changes to their usual diabetes management regimen in response to the alleged issue.At 2:00 pm on the (b)(6) 2024, prior to the alleged inaccuracy issue the customer felt ¿woozy and fainted¿.The patient reported that an ambulance was called and received a glucose reading of ¿10 mg/dl¿ on an unknown ems device.The result on the ems meter was obtained within 30 minutes of the blood glucose reading of ¿195 mg/dl¿ with the subject device and prior to any treatment being received by the patient.The patient advised that at some time ¿after 4:00 pm on the (b)(6) 2024¿ that they received treatment with 20% dextrose iv fluids and was admitted to hospital for 3 days in intensive care.During a review of the call it was noted that the patient in the days leading up to the alleged issue that they had a ¿stomach flu¿ and as a result struggled to eat and drink.The patient attributed this to having low blood sugar.The patient also noted that during their hospital stay they received dialysis for kidney failure.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device as the time of testing and that the customer was carrying out the correct testing procedure.No test strip information was provided so the caa could not confirm if the test trips had expired, if the vial was intact or whether the test strips have been stored correctly.A replacement meter was sent to the patient.This complaint is being reported because the patient reportedly required medical intervention for a possible acute complication of diabetes while using the product.Furthermore, the device could not be ruled out as a contributor to the alleged event.

• Brand Name: ONETOUCH ULTRA2
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 21602185
• Report Number: 2939301-2025-00010
• Device Sequence Number: 18434429
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown