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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dysphasia (2195); Malaise (2359)

Event Date 02/15/2023

Event Type  Injury  

Event Description

On february 15, 2023, the lay user/patient contacted lifescan (lfs) japan, alleging an unusual issue with the onetouch verio vue meter.The complaint was classified based on the customer care agent (cca) documentation and review of the call recording, since the patient disconnected the call and could not be contacted for further information as contact information was unable to be obtained.The patient did not specify when the alleged issue began.The patient informed the agent that the test strip was stuck in the subject meter, and they were unable to pull it out.At the time of the call, the patient stated that they were ¿not feeling well¿ and that they did not know if they were experiencing hyperglycemia or hypoglycemia as they were unable to measure their blood glucose due to the alleged issue.During the call, the patient stated that it makes them worried when they are not able to measure their blood glucose level.The agent noted that the patient¿s voice sounded ¿weak¿.The patient hung up the phone to seek medical attention.No further information could be obtained.During troubleshooting, the cca established that the menu on the subject meter appeared after pressing the ¿ok button¿.The patient was unable to confirm whether the issue was resolved.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while using the product.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT VERIO VUE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 16563683
• MDR Text Key: 311479369
• Report Number: 2939301-2023-00013
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• 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: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female