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

Model Number	022-657
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dyspnea (1816); Hypoglycemia (1912)
Date of Event	04/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, a reporter for the lay-user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch verio2 meter read inaccurately high compared his feelings and/or normal readings and compared to another meter (paramedic¿s meter).The complaint was classified based on the customer service agent (csa) documentation.The reporter stated that the alleged meter inaccuracy began on (b)(6) 2020.The reporter claimed that on (b)(6) 2020, the patient obtained what he felt were inaccurate high readings in the ¿200s mg/dl¿ range with the subject meter.The patient manages his diabetes with oral medication (metformin 500 mg 1 pill daily).The reporter denied the patient made any changes to his usual diabetes management regimen in response to the elevated readings.The reporter claimed that at the time of the alleged issue on (b)(6) 2020, the patient developed symptoms of ¿low blood glucose and couldn¿t breathe.¿ soon after the onset of the symptoms, the emergency medical services were contacted for assistance.On their arrival, the patient¿s blood glucose was reportedly measured at ¿27 mg/dl¿ on the paramedic¿s device.The time difference between the lifescan meter readings and paramedic¿s meter reading was not provided.The patient was reportedly treated with a glucagon injection and was transported to hospital.The patient was admitted to the hospital for 5 days.At the time of troubleshooting, the csa noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion requiring hospitalization after obtaining alleged inaccurate high readings with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 10055030
• Report Number: 2939301-2020-02638
• Device Sequence Number: 2986927
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): Y
• 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): 05/04/2020

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: 022-657
• Device Catalogue Number: 022-657
• Device Lot Number: 4491665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2020
• 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: Hospitalization; Life Threatening; Required Intervention