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	Coma (2417); Sweating (2444); Confusion/ Disorientation (2553)
Date of Event	04/21/2020
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 issue occurred early morning on (b)(6) 2020.The reporter claimed the patient obtained what he felt was an inaccurate high result of ¿243 mg/dl¿ 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 reading.The reporter claimed that early morning on (b)(6) 2020, after the alleged issue began, the patient developed symptoms of ¿sweating, confusion and comatose.¿ the emergency medical services were contacted for assistance.The reporter claimed that on their arrival, the patient¿s blood glucose was measured at ¿10 mg/dl¿ on the paramedic¿s device.The time difference between the lifescan meter reading and paramedic¿s meter reading was not provided.The patient was reportedly treated with a glucagon injection and hospitalization was not required.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 after obtaining an alleged inaccurate high result 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: 10055029
• Report Number: 3008382007-2020-03928
• Device Sequence Number: 2718701
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): Y
• PMA/510(K) Number: K131363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 74 YR