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

Model Number 023-271

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Anxiety (2328); Diaphoresis (2452)

Event Date 09/28/2022

Event Type  Injury  

Event Description

On october 12, 2022, a reporter for the lay-user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy began about 2 weeks prior to contacting lfs.The patient manages their diabetes with a combination of oral medication (1000 mg metformin and 10 mg glipizide).The reporter denied the patient made any changes to their usual diabetes management regimen due to the alleged issue.After the alleged issue began, the patient reportedly obtained a blood glucose reading of ¿229 mg/dl¿ with the subject meter during a hypoglycemic event.At the time of the event, the patient experienced symptoms of ¿sweating profusely and nervous¿.An ambulance was reportedly called for assistance.When the ambulance arrived, they measured the patient¿s blood glucose with the ambulance's meter and a reading of ¿74 mg/dl¿ was obtained.The time difference between the 2 measurements was 30 minutes or less.No further treatment was provided.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca confirmed an approved sample site was used for testing and the correct testing process was being followed.The cca noted the test strips were being stored improperly, outside of their original container.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event 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 ; SZ 6300
• MDR Report Key: 15694123
• MDR Text Key: 302679974
• Report Number: 2939301-2022-03118
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening