MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONETOUCH VERIO FLEX; GLUCOSE MONITORING SYS/KIT

Model Number	023-271
Medical Device Problem Codes	Device Alarm System (1012); Device Displays Incorrect Message (2591); Power Problem (3010)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)
Date of Event	03/10/2025
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.In addition, 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.Furthermore, the reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.
Event or Problem Description
On (b)(6) 2025, the reporter of the lay-user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch verio flex meter displayed an unknown error message, continued displaying ¿apply blood¿ after applying a blood sample and powered off during use.The complaint was classified based on the customer care agent (cca) documentation since the patient could not be reached by phone for follow-up questions.The reporter alleged that the issues occurred on (b)(6) 2025, at an unspecified time.The patient manages their diabetes with a combination of medication (lantus insulin 19 units and glipizide ¿ 1 tablet twice a day) and the reporter denied that the patient took any action in response to the alleged issues.That same day, at an unspecified time after the alleged issue occurred, the patient was ¿shaking, had a convulsion, was dizzy and did not know where they were¿.That same day, around 8 o¿clock (am or pm was not specified), the paramedics were called and a blood glucose reading of ¿40 mg/dl¿ was obtained on an emergency medical services (ems) meter indicating the patient was ¿hypoglycemic¿.The reporter is unsure whether the paramedics provided the patient with any treatment.During troubleshooting, the cca confirmed that the subject device was not being used for the first time.The reporter described a correct testing process, however, the cca was unable to establish whether the correct test strips were being used.Replacement products were sent to the patient.This complaint is being reported because the reporter claims that the patient was unable to test their blood glucose due to the reported issues and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged meter issues began.The subject meter could not be ruled out as a cause or contributor of the event.

• 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 ; 1463383679
• MDR Report Key: 21704314
• Report Number: 3008382007-2025-00007
• Device Sequence Number: 10071833
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• 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): 03/26/2025

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: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: Z2208022X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 08/09/2022
• 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; Life Threatening
• Patient Sex: Unknown