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

Lot Number 5647733

Device Problem Insufficient Information (3190)

Patient Problem Vertigo (2134)

Event Date 06/07/2023

Event Type  Injury  

Event Description

On july 14, 2023, the reporter (the wife) of the patient/lay user contacted lifescan (lfs) canada alleging that her husband¿s onetouch verio reflect meter is not working due to an unknown issue.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter stated on the call that the meter is not working, they don¿t rely on the subject meter anymore and the last time that her husband tested was on (b)(6) 2023.The patient manages his diabetes with a combination of medication (ozempic - once a week and metformin 500 mg - twice a day) alongside diet and/or exercise and the reporter did not specify whether any action was taken in response to the alleged issue.The reporter claimed that after the alleged issue occurred, in the morning on july 14, 2023, the patient ¿lost balance¿.The reporter informed the cca that after the patient lost balance, he got some rest.There was no report of any medical treatment received due to the alleged issue.During troubleshooting, the cca noted that the patient does not correctly store the test strips as he leaves them ¿so long under sunlight¿.The products involved in the complaint were replaced.This complaint is being reported because the patient claims he was unable to test his blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT VERIO REFLECT METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 17375449
• MDR Text Key: 319549558
• Report Number: 3008382007-2023-00040
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5647733
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male