MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number	022-659
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Dizziness (2194); Shaking/Tremors (2515)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio 2 meter was displaying an unknown error message.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged error message began to appear on (b)(6) 2022, at 12:30 pm.The patient manages her diabetes with insulin (fixed dose) and stated that she felt unsure on how many units of insulin to take due to the alleged issue.The patient claimed that after the alleged issue occurred, she reduced her insulin intake from 12 to 6 units in response to the alleged issue at 12:30 pm.The patient started developing symptoms of ¿shakiness and dizziness¿ at 1 pm.The patient denied receiving any medical treatment for the reported symptoms.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time.The cca walked the patient through a retest and the alleged issue remained unresolved.The cca concluded that the error message was caused by the system.A replacement meter was sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the patient reduced her insulin intake due to the alleged error message issue with the subject device.

• Brand Name: OT VERIO 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 13510285
• Report Number: 2939301-2022-03015
• Device Sequence Number: 12086981
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/10/2022

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: 022-659
• Device Lot Number: 4687392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2022
• 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: Life Threatening
• Patient Sex: Female