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

Device Problem Device Handling Problem (3265)

Patient Problems Dizziness (2194); Syncope/Fainting (4411)

Event Date 05/26/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the reporter (the niece) of the lay user/patient contacted lifescan (lfs) france, alleging that the patients onetouch verio 2 meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter alleged that the issue started on (b)(6) 2023, at an unspecified time in the afternoon when the patient received a blood glucose reading of ¿310 mg/dl¿ on the subject meter.Less than 30 minutes later, the patient compared the reading to a blood glucose reading of ¿165 mg/dl¿ which she obtained on a contour plus meter.The patient manages her diabetes with a combination of medication (novo rapid insulin ¿ 8 units three times a day, abasaglar insulin ¿ 25 units in the evening, metformin 500 mg ¿ 1 pill in the afternoon, pravastatine 20 mg ¿ 1 pill in the evening, galvus 50 mg ¿ 1 pill twice a day) and the reporter claimed that she increased her abasaglar insulin with an extra dose in the evening of (b)(6) 2023, in response to the alleged issue.The reporter stated that the patient started feeling ¿dizzy and fainted¿ after the issue occurred on (b)(6) 2023, in the afternoon.The reporter informed the cca that the patient was transported to the hospital for unspecified medical treatment by an hcp on (b)(6) 2023, in the afternoon.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had used an approved sample site to obtain the blood samples.However, the cca established that the patient was not following the correct testing procedure by applying the same blood sample on both tests without washing her hands.The cca noted that the patient did not have control solution at the time of the call to test the subject system.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 17093370
• MDR Text Key: 316851075
• Report Number: 2939301-2023-00039
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female