MAUDE Adverse Event Report: LIFESCAN U.S. LLC ONETOUCH ULTRA2; GLUCOSE MONITORING SYS/KIT

Model Number	024-046
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
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.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.In addition, similar complaints for this issue were 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.
Event or Problem Description
On (b)(6) 2026, the lay user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 meter continued to display the apply sample message instead of counting down and providing a blood glucose result.The complaint was classified based on additional information obtained by the medical surveillance specialist after reviewing the call recording, since the patient disconnected the call and could not be reached for further information.The patient reported that the alleged meter issue began 2 weeks ago around 8:00 am to 9:00 am.The patient manages their diabetes with lantus insulin (20-25 units) and humalog insulin on a self-adjusting dose.The patient did not report taking any action regarding their usual diabetes management regimen in response to the alleged issue.During the call, the patient reported that an unspecified time after the alleged issue began, they suffered dka (diabetic ketoacidosis) because they could not check their blood glucose due to the reported issue and were hospitalized.At the time of troubleshooting, the patient declined to perform a test.The alleged issue remained unresolved.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

• Brand Name: ONETOUCH ULTRA2
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN U.S. LLC; 75 valley stream pkwy; malvern 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: 24990780
• Report Number: 3042301847-2026-00012
• Device Sequence Number: 18715767
• 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): 04/24/2026

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: 024-046
• Device Catalogue Number: 024-046
• Device Lot Number: Y2506008X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 06/11/2025
• 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: Hospitalization; Life Threatening
• Patient Sex: Unknown