MAUDE Adverse Event Report: LifeScan Europe GMBH OneTouch Verio Flex; Glucose Monitoring Sys/Kit

Model Number	024044
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the patient contacted lifescan (lfs), alleging that their onetouch verio flex meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation, since the patient was unable to be reached by phone for additional information.It was not reported when the alleged meter inaccuracy began.The patient claimed obtaining a blood glucose reading of ¿161 mg/dl¿ with the subject meter compared to an unspecified reading on another onetouch meter.It was not reported if the patient took any action regarding their usual diabetes management as a result of the alleged issue.The patient reported that they were hospitalized for a week because their ¿sugar dropped¿, claiming the subject meter was displaying high readings when they were low.No further event details were provided.It was not reported what treatment the patient received.At the time of troubleshooting, the cca noted the test strip vial was intact, and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.This complaint is being reported because the patient reportedly was hospitalized 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.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.

• Brand Name: OneTouch Verio Flex
• Common Device Name: Glucose Monitoring Sys/Kit
• Manufacturer (Section D): LifeScan Europe GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• 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 ; +044()1463382112
• MDR Report Key: 50360201
• Report Number: 3008382007-2026-00014
• Device Sequence Number: 12277732
• Product Code: NBW
• UDI-Device Identifier: 00353885011839
• UDI-Public: 00353885011839
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150214
• 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): 08/20/2026

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: 024044
• Device Catalogue Number: 024-044
• Device Lot Number: Z2505017X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 05/14/2025
• 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; Hospitalization
• Patient Sex: Unknown