MAUDE Adverse Event Report: LIFESCAN INC OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

Device Problem Loss of Power (1475)

Patient Problems Hyperglycemia (1905); Dizziness (2194)

Event Date 11/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra2 meter would not power on after they had stopped using it for a while.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged power issue began around (b)(6) 2022 the patient stated that they manage their diabetes with oral medication (metformin) and continued to follow their usual diabetes management regimen when they were unable to test their blood glucose due to the alleged issue.The patient reported feeling ¿dizzy and was not able to walk very well¿ on (b)(6) 2022, at 5:00 pm.3 hours after the onset of symptoms, the patient reported being treated at the emergency room (er) with insulin.Prior to receiving treatment, the patient¿s blood glucose measured ¿over 400 mg/dl" on the er meter.At the time of troubleshooting, the cca noted there was no indication of misuse to the device.The cca noted the meter did not turn on manually when the power button was pressed and that based on the information provided, the batteries needed to be replaced.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after they were unable to test their blood glucose due the alleged meter issue.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 15802111
• MDR Text Key: 303701647
• Report Number: 2939301-2022-03121
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention