Qmed Staff

October 17, 2013

1 Min Read
FDA Slams Medtronic's Paradigm Insulin Pump for Quality Issues

FDA regulators slammed Medtronic with a warning letter over issues associated with its Paradigm-branded insulin infusion pumps. This comes on top of a Class I recall this past summer over a faulty part in the infusion pump system.On September 19th, regulators alerted the company to violations found during an inspection of its production facility in Northridge, CA. The inspection took place from February 11th to April 12th of this year.In the warning letter, FDA regulators noted a variety of quality control issues. These included a lack of an effective system for the prevention and correction of problems that arise during manufacturing processes. In particular, regulators chided the company for not finding a viable way to prevent mechanical issues with the Paradigm insulin pumps. On top of this, FDA regulators lambasted the company for not providing proof that it had pursued steps that would correct these noted issues. While FDA regulators did note that Medtronic had revised its quality improvement system, it faced more FDA ire for not completing the appropriate employee training under the new system.While 2013 has been a solid year for Medtronic, the Paradigm insulin pumps have turned out to be a significant problem. In June of this year, the Medtronic noted that a mechanical issue in its Paradigm pump could lead to over- or under-delivery of insulin. One month after this, FDA regulators slapped the device with Class I status, indicating that the defect could lead to patient injury or death.

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