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

Model Number	024-046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dizziness (2194)
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, a reporter for 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 and based on additional information obtained from listening to the call recording by a customer quality specialist.The reporter stated that the alleged issue began at an unspecified time one month ago, sometime around the (b)(6) 2025.The reporter claimed that the patient obtained a blood glucose reading of 325 mg/dl with the subject device which they felt was inaccurately high compared to their feelings and/or normal readings.The reporter did not provide information around how the patient manages their diabetes and denied the patient took any action in response to the alleged issue.The reporter stated that the patient started to ¿feel really dizzy¿ and at an unspecified date/time around the (b)(6) 2025 they visited the emergency room.During this visit the patient received a blood glucose reading of ¿63 mg/dl¿ on an unspecified hospital meter and had some food and an oral sugar supplement drink.The reporter also noted that the patient was placed on an ¿iv drip¿ and remained in hospital for around 5 hours; no further specific information was provided regarding the type of treatment given to the patient.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device as the time of testing.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 guided the reporter through a control solution test using the subject meter.The results from this control solution were within the target range provided on the test strips.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: 21869565
• Report Number: 3009698388-2025-00008
• Device Sequence Number: 18103328
• 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): 04/18/2025

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: Y2411011X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/18/2025
• 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