MAUDE Adverse Event Report: LIFESCAN INC. ONETOUCH ULTRA 2; GLUCOSE MONITORING SYS/KIT

Model Number	024-046
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hyperglycemia (1905); Pallor (2468); Syncope/Fainting (4411)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 29, 2025, the lay user/patient¿s spouse contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately low when compared to her feelings and/or normal readings and to a hospital meter.The complaint was classified based on additional information obtained when the medical surveillance specialist reviewed the call recording.The reporter stated that the alleged meter inaccuracy began on august 22, 2025, at 9:00 am.The reporter claimed he measured the patient¿s blood glucose with the subject meter and received low blood glucose readings of ¿85 and 230 mg/dl¿.The reporter stated that the patient¿s diabetes is managed with oral medication (januvia 100 mg, 1 pill daily) and that no changes were made to her usual diabetes management regimen in response to the alleged issue.The reporter claimed that on august 22, 2025, an unspecified time after the alleged issue began, the patient became ¿pale and passed out¿.The reporter stated that he called emergency medical services, and that the patient was taken to hospital by ambulance where she received a blood glucose result of ¿over 400 mg/dl¿ on arrival on the hospital meter.The reporter stated he did not know what treatment was given to the patient.The reporter mentioned the patient was discharged from hospital with the advice given to him by the doctor to get her a new meter.The reporter could not provide any further information.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted an approved sample site was used for testing.The cca noted the reporter did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after obtaining alleged inaccurate low readings with the subject meter and it is not known what treatment the patient received.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
A dhr (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.

• Brand Name: ONETOUCH ULTRA 2
• 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 ; 1463382112
• MDR Report Key: 23080543
• Report Number: 3009698388-2025-00017
• Device Sequence Number: 9812263
• 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): 09/17/2025

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: Y2503021X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 03/13/2025
• 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; Required Intervention
• Patient Sex: Unknown