MAUDE Adverse Event Report: LIFESCAN INC. ONETOUCH ULTRA2; GLUCOSE MONITORING SYS/KIT

Model Number	024-046
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Coma (2417); Alteration in Body Temperature (4568)
Date of Event	10/08/2025
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 her onetouch ultra2 meter was reverting to the set-up mode when attempting to test her blood glucose.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that on (b)(6) 2025, before 12:00 pm, she began to feel bad and attempted to test her blood glucose but was unable to obtain a blood glucose reading due to the reported issue.Despite the alleged issue, the patient took action to increase her glucose level by eating a candy but started feeling ¿very dizzy, cold and became unconscious¿ at around 12:00 pm.The patient reported that at around 12:00 pm, she was taken to the hospital by ambulance where she was admitted because her blood glucose level was ¿too low¿ (no specific reading in hospital was provided) and she was in "coma".The patient stated that she was administered intravenous (iv) glucose and that she stayed in hospital for 2-3 days.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time.The cca educated the patient on the correct testing procedure and walked through a test and the alleged issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after the alleged meter issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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.

• Brand Name: ONETOUCH ULTRA2
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 75 valley stream pkwy; malvern PA 19355
• 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: 23493380
• Report Number: 3009698388-2025-00020
• Device Sequence Number: 8965583
• Product Code: NBW
• UDI-Device Identifier: 00353885011853
• UDI-Public: 00353885011853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• 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): 11/06/2025

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: 024-046
• Device Catalogue Number: 024-046
• Device Lot Number: Y2304010X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 04/12/2023
• 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; Hospitalization; Required Intervention
• Patient Sex: Unknown