Medical Device Startup

User Testimonial

Faulty Equipment Jeopardizes Integrity of Clinical Trial Materials

This medical device company prevents damage to high-value clinical trial samples using the Elemental Machines platform.

Problem

Soon after installation of the Elemental Machines Platform, the Operations Director noticed an unusual temperature profile for a -20C lab freezer, as collected by the Element-T sensor. The freezer stored thermally sensitive, irreplaceable, biological samples that were used in global Phase 3 clinical trials for the company’s coagulometer.

The freezer temperature displayed a cyclical spike about every 12 hours. During these spikes, the temperature inside the freezer rose about 15-20C above the setpoint, often triggering a temperature threshold alert.  Within a couple of days, the team realized that the cyclical temperature spikes were not related to people actually opening the freezers and concluded the behavior was attributed to the freezer performance. The spikes occurred even when no one was on-site, such as weekend and evening hours. To further confound the problem, the freezer display reported a steady temperature of -20C, in contrast to the Element-T reading that recorded all regular temperature spikes. Had the team not had a backup temperature monitoring system they would never have known about this problem. 

Solution

Data collected from the Elemental Machines Platform enabled the company to substantiate the anomaly to its distributor. Had the team relied solely on the steady (and faulty) equipment reading, the anomaly may have gone undetected and likely would have compromised the integrity of the valuable freezer contents. Fortunately, the team relied on the Elemental Machines Platform not only for comprehensive monitoring of its laboratory equipment but also for detecting equipment issues. The medical device company team continues to use the Elemental Machines Connected Platform for lab monitoring and independent verification of environmental parameters. 

 

Results

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