Posted 13 July 2017
By Michael Mezher
The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.
FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017.
A week into that inspection, FDA warned the public that all four of Magellan's LeadCare testing systems (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) could give falsely low results when testing blood drawn from a patient's vein rather than capillary blood.
With the conclusion of its inspection, FDA says healthcare providers should continue to follow it and the US Centers for Disease Control and Prevention's (CDC) earlier recommendations against using the tests with venous blood samples and for retesting patients that are at risk of inaccurate results.
"We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted," said Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostics and Radiological Health.
According to FDA, Magellan did not submit required medical device reports (MDRs) within 30 days of receiving customer complaints about its tests underestimating blood lead levels. One MDR that covered two customer complaints was submitted 201 days late, and another complaint involving eight patients dated 23 October 2014 had not been submitted to FDA as of 15 June 2017.
In several instances, FDA says Magellan also failed to notify the agency of device correction and removal actions within 10 days, including after the company issued "Notice to Customers" letters with recommendations for incubating samples before testing in November 2014 and November 2016.
Additionally, FDA says that Magellan did not evaluate five customer complaints involving false negative results to determine whether an investigation or medical device report was necessary and improperly recorded several customer complaints as support requests, despite the fact that the communications had to do with potential issues with "particulate matter in the treatment reagent, and variation in blood sample results."
Because these reports were classified as support requests, FDA says the company did not evaluate whether they were reportable or warranted further investigation.
FDA also says the company's original design validation "did not account for actual use of the LeadCare systems including immediate analysis of the blood treatment reagent mixture."
According to the agency, the intended use for the three newer LeadCare systems allows for immediate analysis after thoroughly mixing the blood treatment reagent mixture, though the company's validation studies did not look at those specific conditions.
FDA, Form 483