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

Model Number 021-105

Device Problem Device Handling Problem (3265)

Patient Problems Fatigue (1849); Dizziness (2194); Diaphoresis (2452)

Event Date 11/20/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a reporter for the lay-user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to another meter (ambulance meter).The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that on (b)(6) 2021 at 8:55 am, the patient obtained an alleged inaccurate high blood glucose reading of ¿119 mg/dl¿ with the subject meter.The patient manages his diabetes with insulin (23 units in the morning and 13 units at night).The reporter claimed the patient administered his usual dose of 23 units of insulin in response to the elevated result and 35 minutes later developed symptoms of feeling ¿really weak, sweaty, dizzy and looked like he was having a stroke¿.Emergency medical services (ems) were contacted for assistance.When the ambulance arrived at 10:15 am, the reporter claimed the patient¿s blood glucose measured ¿29 mg/dl¿ on the ambulance meter and was then administered glucose 10% intravenous infusion.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted that an approved sample site was used for testing.The cca noted the patient did not have control solution to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after administering insulin based on an alleged inaccurate high result obtained with the subject meter.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12858334
• MDR Text Key: 281856518
• Report Number: 2939301-2021-02988
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2021

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
• Device Lot Number: 4739952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening