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

Model Number	024-046
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Hyperglycemia (1905); Dizziness (2194); Dysphasia (2195); Alteration in Body Temperature (4568); Reduced Blood Flow (4598)
Date of Event	11/20/2024
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.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.
Event or Problem Description
On (b)(6) 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her 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 customer care agent (cca) during a follow-up call with the patient.The patient reported that the alleged issue began on (b)(6) 2024, at 5:30 am and she was unable to obtain blood glucose readings.Prior to the start of the alleged issue, the patient reported that she began developing symptoms described as ¿headache, cannot speak, cannot breathe, dizzy, high temperature and no blood going on her body¿ on (b)(6) 2024, at 5:30 am.On (b)(6) 2024, at 7:00 am, the patient reported attending the doctor¿s office and was hospitalized with a lot of symptoms with a blood glucose value of ¿700 mg/dl¿.During the follow-up call, the patient denied receiving a diagnosis on her condition.The patient stated that she stayed in hospital for 3 days and was treated with injected medication for diabetes but did not recall the name.During the following up call, the patient denied making any changes to her usual diabetes management regimen as a result of the meter issue.She indicated that the subject meter may have contributed to her symptoms since she was unable to obtain appropriate readings but declined to be more specific.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca determined the correct strips were being used for testing.The cca noted the patient did not have test strips available to walk through a test.Replacement products were sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly received medical intervention for an acute high blood glucose excursion after the alleged meter issue began.

• 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: 21156262
• Report Number: 3009698388-2025-00002
• Device Sequence Number: 7630980
• 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): 01/15/2025

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: Y2301008X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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