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

Model Number 021-105

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Chest Pain (1776); Headache (1880); Nausea (1970); Diaphoresis (2452)

Event Date 05/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient contacted lifescan (lfs) usa, alleging that their onetouch ultra 2 meter returned inaccurate low results compared to a hospital meter.The complaint was classified based on the customer care agent (cca) documentation.The patient stated that the alleged inaccuracy issue occurred on the night of (b)(6) 2021 before the patient went to bed.They claimed they obtained results of ¿78 mg/dl¿, ¿68 mg/dl¿ and ¿72 mg/dl¿ on the subject device.The patient manages their diabetes with oral medication (metformin, steglatro and glimepiride).The patient ate a chocolate bar prior to going to sleep in response to the low results however at 04:13 the patient began to experience ¿sweating, nausea, headache and chest pain¿ so went to the hospital emergency room.On arrival, a blood glucose test was performed on a hospital meter and the result was reported as ¿414 mg/dl¿.The hospital then treated the patient with insulin.At the time of troubleshooting, the cca noted the unit of measure was set correctly on the subject meter.The patient did not have control solution to conduct a performance test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment for an acute high blood glucose excursion while using the product and the subject meter could not be ruled out as a cause or contributor to the event.

• 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: 12007614
• MDR Text Key: 256452459
• Report Number: 2939301-2021-02879
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• 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: 06/16/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention