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

Model Number	024-046
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2025, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to their feelings and compared to another meter (unspecified doctor¿s meter).The complaint was classified based on the customer care agent (cca) documentation, since the reporter discontinued the interaction could not be reached by phone for additional information.The reporter indicated that the patient had just purchased the system kit 1 week ago and on an unspecified date obtained high blood glucose results of ¿585, 535 and 600 mg/dl¿ with the subject meter during a low blood glucose episode.It was not reported if the patient takes any medication to manage their diabetes or if they took any action regarding their usual diabetes management due to the reported issue.It was not reported what symptoms the patient experienced.However, the reporter claimed the patient went to an emergency room as a result of the alleged issue and indicated that the patient received a blood glucose result of ¿51 mg/dl¿ on the doctor¿s meter.The time difference between the tests was not reported.It was not reported what type of treatment the patient received.At the time of troubleshooting, it was noted that the patient had reportedly received expired test strips in the system kit that they had recently purchased.This complaint is being reported because the patient reportedly required medical intervention for an acute low blood glucose excursion after obtaining alleged inaccurate high blood glucose readings on the subject meter and it is not known what medical treatment the patient received.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 23345696
• Report Number: 3009698388-2025-00019
• Device Sequence Number: 9461133
• 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): 10/21/2025

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: Y2412025X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/21/2025
• Date Device Manufactured: 12/24/2024
• 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: Required Intervention
• Patient Sex: Unknown