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 Dizziness (2194)

Event Date 08/26/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter is displaying the battery indicator.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged power issue started a few days prior to the call with lfs, at an unspecified time.The patient claimed that the meter was not receiving charge and was displaying the battery indicator.The patient manages her diabetes with an unspecified insulin (twice a day) and stated that she did not take any action in response to the alleged issue.The patient indicated that due to her being unable to test her blood glucose, she started to feel ¿dizzy¿ on (b)(6) 2022, at 11 am.During the call, the patient informed the agent that she was feeling ¿very dizzy¿, and she needed to go to the hospital as soon as possible.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 cca documented that the issue not only occurred on the start-up screen.The cca established that the subject meter has replaceable batteries however, the agent concluded that based on the information provided, the batteries do not need to be replaced.The cca educated the patient that the meter does not need charging.A replacement meter was sent to the patient.This complaint is being reported because the patient claims she was unable to test her 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
• MDR Report Key: 15466316
• MDR Text Key: 300406826
• Report Number: 2939301-2022-03102
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• 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
• Device Lot Number: 4651466
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female