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

Model Number	022-275
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoglycemia (1912); Shaking/Tremors (2515)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On september 24, 2021, the lay user/patient contacted lifescan (lfs) (b)(6), alleging that their onetouch verio iq meter was displaying an ¿error 1¿ message during testing.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged error message began to appear on the evening of (b)(6) 2021.It was not reported what medication, if any, the patient takes to manage their diabetes.The patient claimed they were not able to adjust their diet well as they was unable to test their blood glucose due to the error message appearing.On (b)(6) 2021, an unspecified time after the alleged issue began, the patient claimed they developed symptom of ¿tremor;¿ symptom they associated with hypoglycemia.The patient claimed they self-treated with food and the symptom resolved.The patient denied using any other device to test their blood glucose.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca walked the patient through resolving the issue however the alleged issue was not resolved.Replacement product was provided.This complaint is being reported because the patient claimed they were unable to test their blood glucose due to the reported issue and reportedly developed a symptom suggestive of a serious injury adverse event after the alleged meter issue began.

• Brand Name: OT VERIO IQ METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12630131
• Report Number: 2939301-2021-02964
• Device Sequence Number: 17693072
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 10/08/2021

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: 022-275
• Device Catalogue Number: 022-275
• Device Lot Number: TGJKROTL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening