FDA Warns Luminex of Its Defective In-vitro Diagnostic Device That Has Killed at Least One Patient
Diagnostic failure
FDA – August 12, 2020 – The United States Food and Drug Administration issued an official Warning Letter (MARCS-CMS 606267) to Luminex Corporation concerning one of the company’s defective in-vitro diagnostic devices that failed and caused the death of at least one patient. Luminex’s microsphere-based and (polymerase chain reaction) PCR-based multiplexing system, an in-vitro diagnostic device, is used to diagnose disease and other medical conditions.
The FDA alleges that the company’s aforementioned in-vitro diagnostic device malfunctioned, leading to a “failure to diagnose” event with a patient who had a multi-antibiotic resistant Pseudomonas bacterial infection. The device’s failure to diagnose the patient’s deadly bacterial infection led to the patient not receiving the antibiotic therapy that could have saved the patient’s life. As a result, the patient tragically died two days later due to untreated multi-antibiotic resistant Pseudomonas infection.
In the FDA’s warning letter to Luminex, the “false negative device result may have led to a missed opportunity to initiate effective treatment earlier,” also the “risk of false-negative results could be the inappropriate de-escalation or lack of escalation of antibiotic therapy until subculture sensitivity testing was completed.”
The FDA’s warning letter also cites numerous regulatory violations. The five violations alleged by the FDA include:
- 21 CFR § 820.75(c) – Failure to validate a process when changes or process deviations occurred.
- 21 CFR § 820.100(a) – Failure to adequately establish procedures for corrective and preventive action.
- 21 CFR § 820.200(a) – Failure to adequately establish procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements.
- 21 CFR § 820.50 – Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
- 21 CFR § 820.75(b) – Failure to establish procedures for monitoring and control of process parameters for a validated process.
The FDA’s warning letter to Luminex also alleged several other violations that could open the door to product liability, personal injury, or wrongful death lawsuits if these violations lead to a patient’s injury or death.
If you or a loved one were harmed, injured, or if someone you love tragically died due to a defective diagnostic test or medical device made by Luminex Corporation, contact Parker Waichman LLP at 1-800-YOURLAWYER (1-800-968-7529) for your free consultation. You may also contact us by filling out our online form or using our website’s Live Chat.
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