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

Model Number 023-271

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 06/03/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio flex meter was displaying an ¿error 4¿ and ¿error 2¿ message during testing.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call recording, since the patient was unable to be reached by phone for additional information.During the initial call, the patient indicated that the alleged error messages began to appear 2 weeks prior to contacting lfs.The patient takes metformin medication to manage their diabetes.It was not reported if the patient made any changes to their usual diabetes management regimen when they were unable to measure their blood glucose due to the error messages appearing.It was not reported if the patient developed any symptoms due to the alleged issue, however they mentioned attending the emergency room on june 3 or june 4, 2023, because of diabetes and claimed their ¿sugar was high¿.It was not reported if the patient received any treatment at the emergency room.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca noted the test strips were in good condition.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly attended the emergency room after they were unable to test their blood glucose due to the error messages appearing and it is not known what treatment the patient received.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 17176319
• MDR Text Key: 317630567
• Report Number: 2939301-2023-00043
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 5619429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention