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	Hyperglycemia (1905); Visual Impairment (2138); Vomiting (2144); Diaphoresis (2452); Syncope/Fainting (4411)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that his onetouch ultra2 meter would not power on and he was unable to test his blood glucose.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording, since the patient disconnected the call and attempts to reach the patient for further information were unsuccessful.It was not reported when the alleged power issue began.The patient stated that the meter would not power on despite replacing the battery.During the call, the patient mentioned that he purchased the meter 2 months ago.It was not reported how the patient manages his type 2 diabetes, or if he made any changes to his usual diabetes management regimen due to the alleged issue.During the call, the patient reported that on an unspecified date, he was hospitalized and in intensive care because his blood glucose ¿went high¿ and was unable to test his blood glucose.No further event details were provided.At the time of troubleshooting, the cca noted the patient is using the correct battery and there was no indication of misuse of the device.The cca noted the meter would not power on manually when the power button was pressed.The cca documented 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 required hospitalization due to an acute complication of diabetes while using the product.There is insufficient information, including treatment and clear temporal relationship, to rule out the contribution of the subject meter 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.
Additional Manufacturer Narrative
On january 21, 2025, the patient contacted lfs and provided additional event information.It remains unclear when the alleged issue began.The patient stated that he manages his diabetes with oral medication (glimepiride and metformin) and denied making any changes to his usual diabetes management regimen due to the alleged issue.The patient clarified that he experienced symptoms of ¿sweating, could not see, throwing up and passed out¿ (exact date unclear).The patient stated that an ambulance was called, and that he was taken to hospital where he received a blood glucose result of ¿687 mg/dl¿ on the hospital meter.The patient mentioned that he was admitted to the intensive care unit and was treated with insulin, and glimepiride and metformin medication.The patient stated that he was hospitalized for 10 days and that he attributed the reported injury to the meter not turning on.

• 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 ; 1463383679
• MDR Report Key: 21147681
• Report Number: 3009698388-2025-00001
• Device Sequence Number: 9088657
• 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,Followup
• Report Date (Section B): 02/06/2025

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: Y2210006X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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