Medtronic ($MDT) got slapped with an FDA warning letter over problems with its Paradigm insulin infusion pumps. The action adds to the Class I recall status regulators assigned when problems surfaced with a faulty part in the system's infusion sets over the summer.
The FDA's Sept. 19 letter to the company reflects alleged violations found during an inspection of Medtronic's Northridge, CA, manufacturing facility from Feb. 11 through April 12, 2013.
Regulators spotted a number of quality system violations. Among the issues for which they cited Medtronic: not having a viable system that enables correction and prevention of manufacturing problems. Specifically, the FDA also criticized the company for not figuring out how to prevent future mechanical snafus with its Paradigm insulin pumps, and for not providing proof that it has taken steps to correct the issues. While the agency credits the company for revising its quality improvement system, it faults Medtronic for not completing employee training under the new regimen. And the list continues.
Medtronic explained to FierceMedicalDevices via email that the warning letter came as part of the FDA's review process for the newly-approved MiniMed 530G (a preliminary artificial pancreas system), which uses the same technology platform as Paradigm. Amanda Sheldon, director of public relations for Medtronic's diabetes division, noted that the company has been working hard with regulators to addresses concerns stipulated in the warning letter.
"Specific to the warning letter, as previously mentioned during recent earning's calls and public filings, Medtronic has been working swiftly and comprehensively to address these issues over the past several months. The items covered are related to 6 categories: corrective and preventative action, complaint handling processes, process validation, process monitoring, design control and general good manufacturing processes (GMP)," she said. "The warning letter acknowledges the extensive work we have already completed to address many of the observations noted by the FDA. The company will respond with additional steps that will be taken to address any concerns raised as quickly as possible."
Sheldon added: "It is important for patients and physicians to know that we stand behind the quality of our products and that no action is presently required by patients or physicians related to this letter. We take these findings seriously and are working closely with the FDA. Medtronic is committed to quality and patient safety and are committed to continuously improving our quality processes."
Medtronic generally has had a strong year, but its Paradigm insulin pumps have emerged as a problem. In June, the Minnesota device giant warned that a mechanical issue involving a part used with the Paradigm pumps could lead to the delivery of too much or not enough insulin. A month later, the FDA upgraded the issue to a Class I recall--its most serious label. Their action affected Paradigm infusion sets, which are used with the Paradigm insulin pumps.
On June 7, Medtronic issued what is known as an "urgent medical device safety notification," noting that the Paradigm insulin pump could give too much or too little insulin if insulin or other fluids touched the inside of the system's tubing connectors. The end result: patients could face either hypoglycemia or hyperglycemia, because fluids can temporarily block the vents that let the pump work properly.
Australian regulators also issued an advisory over the Paradigm insulin pumps earlier this year, because of issues including lost parts and sensor graph malfunctioning.
- here's the FDA's warning letter
Editor's note: This story has been updated to include comments from Medtronic.