Medtronic Warning Letter
Late yesterday the FDA posted a warning letter sent to Medtronic (NYSE:MDT) back on June 1, 2009 which outlines some serious issues related to their MiniMed Paradigm insulin pumps. According to the letter; (Diabetic Investor added the highlighting)
“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).
a) Complaint No. (b) (4) states that the reported complaint was not reportable as an MDR to the FDA based on testing of the returned MiniMed Paradigm® Insulin Pump. Information in the complaint indicated that the patient was hospitalized for diabetic ketoacidosis allegedly following battery problems with the pump. The complaint file states that analysis of the pump did not find a battery problem. Your firm concluded that although "information does suggest that a device malfunction occurred," the malfunction was unlikely to result in death or injury if it were to recur.
However, a review of the MDRs submitted by your firm to the FDA through MedWatch shows that your firm has submitted serious injury MDRs with a diagnosis of diabetic ketoacidosis resulting from the use of the MiniMed Paradigm® Insulin Pump. Since your firm has previously reported these MDRs where a patient had been hospitalized for diabetic ketoacidosis from the use of the MiniMed Paradigm® Insulin Pump and your firm received a complaint of a similar nature, this device malfunction, if it were to recur, would be likely to cause or contribute to the same serious injury. Furthermore, under 21 CFR 803.3, "Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury…."
Based on the information in the complaint file, device failure or malfunction may have contributed to or caused the user’s hospitalization and the device’s malfunction would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. As a result, this serious injury is a reportable MDR event under 21 CFR 803.50(a). Your firm did submit MDR (b) (4) for this complaint. The "Date of Event" and the "Date of Report" are listed as May 30, 2007. Your firm reported this as a serious injury on the Mandatory Reporting Form, FDA-3500A, on November 14, 2008, which is 18 months after the day that your firm received information of an MDR reportable event.
b) Complaint (b) (4) states that the reported complaint was not reportable as an MDR to the FDA based on testing of the returned MiniMed Paradigm® Insulin Pump. The information in the complaint indicated that the user contacted your firm because the user had a blood glucose level of 456, and that the user’s MiniMed Paradigm® Insulin Pump had failed to alarm when it stopped delivering insulin. The user was subsequently hospitalized and diagnosed with diabetic ketoacidosis. Follow-up revealed that the user had trouble keeping the user’s blood glucose level down, and when the user replaced infusion sets, the cannulas were bent. The complaint record states that, (b) (4) Under 21 CFR 803.3, "Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury…." In this instance, the patient had complained of a potential device failure, and the patient was subsequently hospitalized for diabetic ketoacidosis. Based on the information in the complaint file, because your firm was aware of information that reasonably suggested that the user’s MiniMed Paradigm® Insulin Pump may have caused or contributed to a serious injury, you were required to report this event to FDA as an MDR within 30 calendar days of receiving or otherwise becoming aware of this information, under 21 CFR 803.50(a).
We have reviewed your responses dated January 20, 2009, and March 31, 2009, and our conclusions follow:
Your responses state that MDR reports were submitted for the complaints identified above. Your firm has also updated your procedure (b) (4) Medical Device Report (Effective Date: December 17, 2008), to reflect new criteria for MDR reporting, and re-trained your employees on the new procedure on December 16, 2008. The adequacy of your corrective and preventive actions will be determined during the next inspection.
6) Failure to have a person who is qualified to make a medical judgment reasonably conclude that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur, as required by 21 CFR 803.20(c)(2). Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers, under 21 CFR 803.20(c)(2).
Our investigators determined that a product reporting specialist was making decisions about MDR reportability for the MiniMed Paradigm® Insulin Pumps. The training record for this particular employee showed that this person only had a high school diploma with some additional in-house training.”
Reading through this letter a few points quickly come to mind:
1. As we have pointed out on several occasions building an insulin pump is one thing, effectively running an insulin pump company is another.
2. Medtronic’s cost cutting efforts have serious consequences. Simply put Medtronic is trying to get by on the cheap hiring unqualified lower paid personal to handle serious situations.
3. Medtronic will make every effort to shape this letter as a non-event, just as they did when the MRI issue became public. The fact is these are serious issues which unfortunately have become all too common at Medtronic.
4. Diabetic Investor can only imagine how Medtronic will handle issues when their semi-closed loop system comes to market here in the United States.
5. The folks at Medtronic must be wondering with all the changes that have occurred in the insulin pump market why the heck they bought MiniMed in the first place.