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 Dizziness (2194); Presyncope (4410)

Event Date 09/23/2022

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.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that on the morning of (b)(6) 2022, they were unable to test their blood glucose due to the alleged power issue.The patient stated that they manage their diabetes with a fixed dose of insulin (humalog and lantus) and skipped their normal dose of insulin that morning due to the alleged issue.The patient reported developing symptoms of feeling ¿dizzy and almost fainted¿ that same morning, after the alleged issue occurred.The patient stated they were treated by another person with something sweet to eat.The patient denied using any other device to test their blood glucose.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time and there was no indication of misuse to the device.The cca noted the meter would not power on manually when the power button was pressed or when a test strip was inserted.The cca noted that based on the information provided, the batteries did not needed replacing.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly required the assistance of a third-party for treatment of hypoglycemic symptoms after they were unable to test their blood glucose due to the alleged power 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: 15514871
• MDR Text Key: 300890049
• Report Number: 2939301-2022-03108
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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
• Device Lot Number: 4741156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention