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

Model Number 023-194

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphasia (2195); Sweating (2444); Alteration In Body Temperature (2682)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020, the lay-user/patient¿s spouse contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch verio flex meter read inaccurate.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 (exact time not reported).The reporter claimed the patient obtained an alleged inaccurate result of ¿8.5 mmol/l¿ with the subject meter.This was reportedly a normal result for the patient.The reporter informed the csa that the patient manages his diabetes with a fixed dose of insulin (type/dose not reported) and denied the patient made any changes to his usual diabetes management regimen in response to the alleged inaccurate result.The reporter claimed that on (b)(6) 2020 at 4:25 pm, after the alleged issue began, the patient started developing symptoms of ¿sweating profusely, feeling the body with a sensation of overheat, his eyes rolled to the back of his head and was unable to speak.¿ the reporter claimed she proceeded to contact the emergency medical service (ems) for assistance and when they arrived at 4:51 pm, the patient¿s blood glucose tested ¿2.1 mmol/l¿ on the ems device.The reporter claimed the patient was treated with intravenous (iv) glucose, then after 15 minutes, his blood glucose tested ¿7.4 mmol/l¿ on the ems device.The following day, the reporter claimed a blood glucose test was performed with the subject meter and a normal result for the patient of ¿8.5 mmol/l¿ was obtained.During troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter and that the same approved sample site was used for testing.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 the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 10104817
• MDR Text Key: 193070605
• Report Number: 2939301-2020-02647
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010719
• UDI-Public: 00353885010719
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/25/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 023-194
• Device Catalogue Number: 023-194
• Device Lot Number: 4567710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention