Medical device company pleads guilty in case of faulty cable testing device

BOSTON (WWLP) – The manufacturer of a blood lead detection device has agreed to plead guilty to covering up a device malfunction that led to false test results.

According to the Department of Justice (DOJ) Diagnostyka Magellan limited liability company, a medical device company based in Billerica, Massachusetts, failed to inform customers or the FDA that three of its LeadCare devices (LeadCare Ultra, LeadCare II and LeadCare Plus) malfunctioned when they were used to test venous blood samples. The outage caused an estimated tens of thousands of children and other patients to receive inaccurate test results for low lead levels.

These devices are used to detect lead levels and lead poisoning in the blood using venous blood samples (i.e. blood drawn through the arm) or from a fingerstick. LeadCare II, which was used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States between 2013 and 2017. LeadCare Plus and LeadCare Ultra were mainly used for testing venous samples.

Court records show that Magellan first learned that a failure of the LeadCare Ultra device could result in inaccurate lead test results – particularly results that were falsely low – during the FDA approval process in June 2013. However, Magellan released LeadCare Ultra launched in December 2013 without informing customers or the FDA of the defect.

Additionally, tests conducted in 2013 revealed that the same failure occurred in the LeadCare II device, Magellan’s most profitable product. It wasn’t until November 2016 that the company informed customers and the FDA about the failure.

The company will plead guilty to violating the Federal Food, Drug and Cosmetic Act and pay a fine of $21.8 million, forfeiture of $10.9 million and at least $9.3 million in patient restitution. The resolution also includes a deferred prosecution agreement to resolve fraud charges against the company as part of the conspiracy.

Magellan will compensate all patients who demonstrate harm as a result of false test results. If you or a family member believe you received an inaccurate blood lead test result using the LeadCare device between 2013 and 2017, please complete the questionnaire on the FBI website. Information about the status of the case can be found on the U.S. Attorney’s Office website.