FDA Inspection Reveals Adulterated Synchromed® II Insulin Pumps Massey, Stotser & Nichols P.C. Attorneys Birmingham Alabama

FDA Inspection Reveals Adulterated Synchromed® II Insulin Pumps

Posted by: Micah Adkins
July 01, 2009
Topic: DANGEROUS DRUGS

Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the "Act"), 21 USC Section 321(h), the federal government has the authority to regulate devices that are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. The Food and Drug Administration (FDA) conducts inspections of manufacturing facilities that manufacture such devices. Recently, during an inspection of a Medtronic Inc. manufacturing facility in Puerto Rico, FDA inspectors discovered adulterated Synchromed® II Insulin Pumps. In other words, the pumps were not manufactured in conformity with with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation. See 21 C.F.R. Part 820. According to the FDA, the manufacturer's failure to follow CGMP has resulted in infections by users of Synchromed® II Pump serial numbers NGP319205H and NGV416698H. Click HERE for the FDA warning letter sent to Medtronic.

The FDA's warning letter cites additional adverse events associated with the MiniMed Paradigm® Insulin Pump. Specifically, the FDA's stated in pertinent part: Our inspection also revealed that your MiniMed Paradigm® Insulin Pumps are misbranded under section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

5) Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market: (1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a).

Incidents of diabetic ketoacidosis resulting from use of the MiniMed Paradigm® Insulin Pump have been reported by Medtronic through MedWatch. Diabetic ketoacidosis can be life threatening, require hospitalization and can cause serious injury.

If you or a loved one has used a Synchromed® II Insulin Pump or MiniMed Paradigm® Insulin Pump and have suffered a serious injury and required hospitalization, your legal rights may have been violated. For a free consultation contact attorney Micah Adkins.