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

Model Number 023-271

Device Problem Loss of Power (1475)

Patient Problems Hyperglycemia (1905); Chills (2191); Dizziness (2194)

Event Date 07/14/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient¿s spouse contacted lifescan (lfs), alleging that the patient¿s onetouch verio flex meter powers off during use.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged power issue began on (b)(6) 2022 at 10:00 am.The reporter stated that the patient manages their diabetes with oral medication (metformin 1000 mg; glipizide 5 mg) and claimed the patient continued to follow their usual diabetes management routine in response to the alleged issue.The reporter claimed that during the call to lfs, the patient started to develop symptoms of feeling ¿dizzy and chills¿.The reporter advised that were going to give the patient tea with lemon leaves, anise and cinnamon and that they might take the patient to hospital.During troubleshooting, the cca noted the subject meter was being used for the first time and there was no indication of misuse to the device.The cca educated the reporter on how to turn the meter on in the correct way and the alleged issue was resolved.The cca walked through a retest and a blood glucose reading was successfully obtained (the patient received a result of ¿280 mg/dl¿).Replacement products were sent to the patient.The cca contacted the reporter in a follow-up call on (b)(6) 2022 and the reporter confirmed the patient¿s health is now fine.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged meter 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: 15170541
• MDR Text Key: 297309692
• Report Number: 2939301-2022-03075
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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: 4837597
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening