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

Model Number	023-271
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	Headache (1880); Hypoglycemia (1912)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verio flex meter was powering off during use.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist (mss) during review of the call recording.The patient alleged that the issue started more than a week prior to the call with lfs, at an unspecified time.The patient manages their diabetes with a combination of medication (jardiance insulin ¿ 50 mg at night and metformin ¿ 2 pills in the morning and at night).The patient mentioned that they were fasting for 4 days on a liquid diet and indicated that this must have lowered their blood sugar.In the morning of (b)(6) 2024, they went to the hospital for an unrelated procedure.The patient claimed that the nurse checked their blood sugar on a hospital device and obtained a reading of ¿60 mg/dl¿.The patient stated that the nurse added some sugar water in their iv to bring the sugar up.The patient initially denied developing symptoms and mentioned that they were not aware of the lower blood sugar levels.It was noted that, later in the call, the patient indicated they did have some ¿headaches¿ in the week before the hospital visit.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and there was no indication of misuse of the device.The cca educated the patient on the meter¿s behavior and auto-shutoff but the issue remained unresolved.The cca concluded that the battery did not need replacing.The patient refused to send the product back to lfs and did not want a replacement meter.This complaint is being reported because the patient claims they was unable to test their blood glucose due to the reported issue and reportedly received medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure due to an acute complication of diabetes.

• Brand Name: ONETOUCH VERIO FLEX
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 21175397
• Report Number: 2939301-2025-00005
• Device Sequence Number: 4287350
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: Z2409011X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Date Device Manufactured: 09/06/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown