iRhythm Technologies’ mislabeling of a cardiac monitor and its component software as well as failure to report serious adverse events, including two deaths, netted the devicemaker an FDA warning in late May.

Problems observed during an FDA inspection of iRhythm’s device manufacturing facility in Cypress, Calif., last summer have not been resolved, the agency said, in a May 25 warning letter to the company.

The Zio AT System was FDA-cleared for long-term monitoring of arrhythmia events in noncritical-care patients, the agency noted, but the company’s marketing materials claimed the system is intended for “near real-time monitoring” and for “high-risk patients,” although it was not cleared for that indication.

In response to the inspection observations, iRhythm had proposed several labeling changes, such as removing the term “high-risk” and replacing the phrase “near real-time monitoring” with “near real-time cardiac event monitoring.” But the agency said the response was inadequate because the proposed labeling “still represents a major change or modification in intended use” that would require submission of a new 510(k).

The FDA also highlighted medical device reporting (MDR) failures related to the device’s transmissions, “which revealed two deaths as well as significant arrythmias that were not reported to physicians.” The FDA said the company’s records reviewed during the inspection “indicate that your firm has been aware of customer complaints related to this issue since at least 2019.”

The FDA urged the company to take “prompt actions” to address the violations and bring the products into compliance.

In a comment to FDAnews, iRhythm said the company “has already taken action intended to address certain items identified by the FDA in their 483 observations and intends to take appropriate action to further address the items identified in the 483 observations and the warning letter.”

Related Topics