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 Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 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, the lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra 2 meter was reading inaccurately high compared to their feelings/normal results.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call.The patient stated that the alleged issue began at 02:00 pm on (b)(6) 2025.The patient claimed obtaining blood glucose readings of ¿201 mg/dl and 193 mg/dl¿ with the subject device which they felt were inaccurately high compared to their feelings and/or normal readings.The patient manages their diabetes with self-adjusted insulin (nph insulin, 8 units in the morning and novolin r, 8 units in the morning) and they denied making any changes to their usual diabetes management regiment in response to the alleged issue, reporting that they continued with their usual activities.The patient reported that at around 02:00 pm on (b)(6) 2025 that they started feeling ¿confused¿, stating they were ¿not processing everything quite right¿ and experienced ¿typical low blood sugar symptoms¿.The patient reported that an ambulance was called and that they received a glucose reading of ¿48 mg/dl¿ on an unknown emergency medical services (ems) device in the ambulance.The result on the ems meter was obtained greater than 30 minutes after the blood glucose readings of ¿201 mg/dl and 193 mg/dl¿ with the subject device and prior to any treatment being administered.The patient advised that they received treatment with a ¿glucagon iv injection¿ at around 03:15 pm on the (b)(6) 2025 in the ambulance, and again at between 05:30 pm- 06:00 pm in the hospital.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.The cca also noted that the patient 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 required medical intervention for a possible acute complication of diabetes while using the product.Furthermore, the device could not be ruled out as a contributor to the alleged event.

• 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: 22289017
• Report Number: 3009698388-2025-00011
• Device Sequence Number: 18361738
• 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): 06/19/2025

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: Y2501025X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/19/2025
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown