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

Model Number	024-046
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	Fall (1848); Hyperglycemia (1905); Dizziness (2194)
Date of Event	05/22/2025
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 their onetouch ultra2 meter powers off during use.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged issue began at an unspecified date and time in (b)(6) 2025.The patient stated that because they were unable to obtain blood glucose readings, they stopped using the meter.The patient manages their diabetes with oral medication (jardiance) with diet and/or exercise.The patient denied making any changes to their usual diabetes management regimen as a result of the alleged issue.The patient reported experiencing symptoms of feeling ¿very lightheaded and falling down¿ for the past month, since the alleged issue began.Due to the symptoms, the patient stated that on (b)(6) 2025, they went to the hospital where they were found to have "very high blood glucose levels".The patient stated that they were hospitalized for 3 days and administered insulin each day (different doses) to lower their glucose levels.The blood glucose test results at the hospital were not provided.The patient was discharged on (b)(6) 2025 and advised to monitor their glucose levels with the meter.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and that there was no indication of misuse of the device.The cca educated the patient on the meter¿s behavior and auto-shutoff however the alleged meter issue remained unresolved.The cca noted that based on the information provided, the battery did not need to be replaced.A replacement product was 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.
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.; 20 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 ; 1463382112
• MDR Report Key: 22207863
• Report Number: 3009698388-2025-00010
• Device Sequence Number: 7667550
• 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): 06/13/2025

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
• Device Model Number: 024-046
• Device Catalogue Number: 024-046
• Device Lot Number: Y2302047X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 02/24/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown