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	Hypoglycemia (1912); Dizziness (2194); Malaise (2359); Diaphoresis (2452); Presyncope (4410)
Date of Event	08/16/2025
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 to her feelings and/or normal readings and compared to another meter (relion), and to a continuous glucose monitoring (cgm) device.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on the morning of (b)(6) 2025, at around 10:00 am.The patient reported obtaining what she felt was an inaccurate high blood glucose reading of ¿197 mg/dl¿ with the subject meter and compared the meter reading to an unspecified reading obtained on her other meter then to a reading of ¿137 mg/dl¿ obtained on her cgm device.The patient manages her diabetes with insulin lispro on a self-adjusting dose.The patient stated that based on the high reading of ¿197 mg/dl¿, she took an increased dose of insulin according to her doctor¿s recommendation.1 hour later, the patient reported having a low blood glucose episode with symptoms of ¿feeling bad, sweaty, dizzy and like passing out¿.The patient reported treating herself using baqsimi (glucagon nasal spray) to raise her blood glucose levels.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca determined that an approved sample site was used for testing, that the correct testing process was being followed and that the test strips were in good condition.The cca noted that the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after taking insulin based on an alleged inaccurate high result obtained with the subject meter.
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 ; 1463382112
• MDR Report Key: 22974290
• Report Number: 3008382007-2025-00018
• Device Sequence Number: 9549539
• 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): 09/04/2025

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: Z2501015X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 01/11/2025
• 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
• Patient Sex: Unknown