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

Model Number 023-271

Device Problem Battery Problem (2885)

Patient Problem Shaking/Tremors (2515)

Event Date 01/17/2023

Event Type  Injury  

Event Description

On january 18, 2023, the lay-user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio flex meter displayed the ¿battery indicator¿ after replacing the batteries.The complaint was classified based on the customer care agent (cca) documentation during the initial call.The patient reported that the alleged power issue began on (b)(6) 2023, at 7:30 pm.The patient manages his diabetes with a combination of oral medication with diet and/or exercise (2 pills per day, type unknown) and he stated that he increased his medication in response to the alleged issue.Immediately after the issue occurred, the patient developed the symptom of ¿shaking¿.The patient informed that he treated himself with coca cola and one bread.The patient denied using any other device to test his blood glucose.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and there was no indication of misuse to the device.The patient denied that the issue only occurred on the start-up screen.Based on the information provided by the patient, the cca concluded that the batteries did not need replacing.The cca managed to resolve the issue on the call and the patient received an actionable unspecified result.Replacement products were sent to the patient.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.

• 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
• 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: 16219548
• MDR Text Key: 307877304
• Report Number: 3008382007-2023-00002
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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
• Device Lot Number: 5600787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2023
• 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 Sex: Male