FBI investigation relating to Lead Care devices

The information below is copied from the “Seeking Information in Magellan Diagnostics Investigation” article posted on April 5, 2023 and was not written by HVHD.

The FBI’s Boston Division is seeking information in the investigation of three former senior executives for Magellan Diagnostics. 

The indictment alleges that from June 2013 through December 2017, the defendants repeatedly misled customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices—LeadCare Ultra, LeadCare II, and LeadCare Plus. By allegedly hiding the malfunction and later deceiving customers and the FDA about when they discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, the defendants allegedly caused an estimated tens of thousands of children and other patients to receive inaccurate lead test results. 

In other words, patients who were tested with a LeadCare device from 2013 through 2017 may have received results that were inaccurate—for example, a patient’s blood lead level may have been above the CDC-recommended initial threshold of concern of 5 micrograms per deciliter (μg/dL), but the LeadCare device reported a blood lead level below 5 μg/dL. 

In 2017, the FDA ultimately found that the LeadCare Devices should not be used with venous samples, leading to a recall of all LeadCare Devices using venous samples.  At the time, the Centers for Disease Control and Prevention (CDC) recommended that patients should be retested for blood lead levels if they are (a) younger than 6 years old and (b) previously had a venous blood test result of less than 10 µg/dL analyzed using a Magellan Diagnostics’ LeadCare device. 

According to court documents, as referenced by the CDC, there is no safe level of lead in the blood. Lead exposure may cause irreversible lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure, especially those from low-income households and those who live in housing built before 1978 because those homes are more likely to contain lead-based paint and have fixtures containing lead.

If you believe you and/or your minor dependent(s) received an inaccurate lead test from a LeadCare device, or that you have information pertinent to this investigation, please fill out this short form.

The FBI is legally mandated to identify victims of federal crimes it investigates. Victims may be eligible for certain services, restitution, and rights under federal and/or state law. Your responses are voluntary but may be useful in the federal investigation and to identify you as a potential victim. Based on the responses provided, you may be contacted by the FBI and asked to provide additional information. All identities of victims will be kept confidential.

The information below is copied from the CDC “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears” article updated on March 21, 2023 and was not written by HVHD.

CDC is collaborating with the Food and Drug Administration (FDA) and state and local health departments to investigate a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa. The outbreak strain, carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA), had never been reported in the United States prior to this outbreak. The outbreak is associated with multiple types of infections, including eye infections. The investigation to date has identified artificial tears as a common exposure for many patients.

At this time, CDC and FDA recommend clinicians and patients stop using EzriCare or Delsam Pharma’s Artificial Tears products pending additional guidance from CDC and FDA.

Patient Information

Patients should stop using EzriCare or Delsam Pharma’s Artificial Tears pending additional information and guidance from CDC and FDA. If patients were advised to use EzriCare or Delsam Pharma’s Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for recommendations about alternative treatment options.

Patients who have used EzriCare or Delsam Pharma’s artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately. At this time, there is no recommendation for testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

Eye infection symptoms may include:

  • Yellow, green, or clear discharge from the eye
  • Eye pain or discomfort
  • Redness of the eye or eyelid
  • Feeling of something in your eye (foreign body sensation)
  • Increased sensitivity to light
  • Blurry vision

FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program. Consumers may also report adverse reactions by contacting FDA’s Consumer Complaint Coordinators.

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