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 Codes	Fatigue (1849); Nausea (1970); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio flex meter read inaccurately high compared her feelings and/or normal readings.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.The patient reported that on (b)(6) 2025, at 8:07 pm, she obtained a blood glucose reading of ¿107 mg/dl¿ with the subject meter during a hypoglycemic event.The patient reported experiencing symptoms of ¿shaking, weakness, fatigue, confusion and nausea¿.The patient stated that an ambulance was called and when the ambulance arrived, she received a blood glucose result of ¿63 mg/dl¿ on the ambulance meter at 8:20 pm.During the call, the patient stated that she was treated with saline and given something sweet to drink and was transported to the emergency room (er).The treatment provided at the er was not provided.During the call, the patient mentioned that she has brittle diabetes and has hypoglycemia every other day.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca confirmed that the test strip vial was intact, and that the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to test the subject meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
A dhr (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 ; 1463382112
• MDR Report Key: 21649464
• Report Number: 3008382007-2025-00006
• Device Sequence Number: 13104357
• 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): 03/19/2025

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: 024044
• Device Catalogue Number: 024-044
• Device Lot Number: Z2410023X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/19/2025
• Date Device Manufactured: 10/30/2024
• 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
• Patient Sex: Unknown