Leading Glucose Monitoring Manufacturer

# Smarteeva Solves High-Volume Complaint Handling for a Leading Glucose Monitoring Company

Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries.

VP of Quality Operations

Leading Glucose Monitoring Manufacturer

5M+

Annual complaints processed without performance loss

300K+

MDRs handled annually on the platform

Minutes

MDR creation to FDA submission time

About

Dexcom

One of the largest manufacturers and producers of glucose monitoring systems required an overarching system for Post-Market surveillance and effective complaint management. Despite having a quality system, the ever-changing business landscape and growing volumes made scalability impossible without a new approach.

Industry

Diabetes Technology / Glucose Monitoring

Painpoint

3M annual complaints overwhelming existing QMS, 25-step complaint lifecycle, untouchable customizations

> Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries.

**The Challenge**

5M annual complaints overwhelming existing QMS, 25-step complaint lifecycle, untouchable customizations

- Previous QMS not scalable: 5M+ annual complaints and 300K+ MDRs needed speed and responsiveness
- Extensive customizations made the previous system untouchable; any update caused outages
- 25 process steps required to go through the complaint lifecycle
- User community could not track information changes or make informed regulatory decisions

**How Smarteeva Solved It**

Smarteeva partnered with the customer to design and deploy a purpose-built solution:

1. Scalable platform with no performance loss at 5M complaints and 165M+ Audit Trail entries
2. User-friendly Audit Trail UI to help users quickly identify critical information
3. Fully automated MDR reporting: creation, completion, and FDA submission in minutes
4. Automated decision trees and regulatory reports for EU and multiple countries
5. Scalable integration with customer service applications exchanging 250K+ daily messages

## Results

5M+

Annual complaints processed without performance loss

300K+

MDRs handled annually on the platform

Minutes

MDR creation to FDA submission time

250K+

Daily messages exchanged via service integration

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