MiniMed Recall – This is NOT a field correction this is a Recall
Yesterday an unidentified Medtronic (NYSE:MDT) official issued the following statement to Insulin-Pumpers.Org:
“Recently, Medtronic became aware of cases where exposure to strong
magnetic fields like Magnetic Resonance Imaging (MRI) resulted in
damage to Medtronic Paradigm insulin infusion pumps. Medtronic has
taken this situation very seriously, and we have voluntarily
notified our patients, physicians and the FDA about these
incidences, reinforcing the need for caution when using our insulin
infusion pumps while in close proximity to strong magnetic fields
The FDA has agreed with our assessment of the situation, and
categorized this announcement as a Class II Field Correction,
requiring us only to notify patients of the potential risk MRIs pose
to their insulin pumps. Patients should not be concerned or take
any further action unless they believe their Paradigm insulin pump
has been exposed to an MRI machine. Patients should not return
their Paradigm insulin pump to Medtronic unless they believe this
exposure has taken place.
Extensive testing with other magnetized devices such as airport
metal detectors, electronic article surveillance equipment and
cellular phones will not adversely affect pump operation.”
According to this post Medtronic claims they notified their patient base in April in regards to this issue, a statement which is consistent with the letter Diabetic Investor attached to yesterday’s email alert.
First it should be noted that the FDA did NOT issue a Field Correction they classified this situation as a Class II recall. Medtronic’s attempt to minimize the extent of the problem by calling it a field correction is disingenuous when you examine the FDA database. Diabetic Investor searched the MAUDE (Manufacturer and User Facility Device Experience) database. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. From the beginning of 2007 to June 29th, 2007 there 581 events related to MiniMed insulin pumps.
Although not every report contained an explanation Diabetic Investor found 7 events that specifically mention MRI’s or X-Rays.
Model Number Event Date
Looking over this table two interesting trends emerge:
1. 1. Most notably 5 of the 7 reported events occurred well after Medtronic sent out letters warning patients over this issue.
2. 2. All of the pumps are from the 700 series.
It should be noted that Diabetic Investor only counted the events that specifically mentioned MRI’s or X-rays, we did not include events that contained explanations which had similar characteristics to the issue as they did not specifically mention either MRI or X-Ray. Furthermore there were several reports of deaths or diabetic comas attributed to severe hypoglycemia which only reinforces our belief that the FDA incorrectly classified this recall as a Class II rather than a Class I.
The fact all the events come from the 700 series may point to another problem, are Medtronic’s pump trainers and/or educators properly educating patients and physicians of this issue? Diabetic Investor found it interesting that we could not find even one event tied to the older 500 series. It is well known that there has been a high level of turnover in the MiniMed sales force and the company has put additional pressure on reps by increasing their sales quota. The question needs to be asked; Are sales reps sacrificing pump education, a time consuming process, in an effort to meet their increasing sales quotas?
Additionally it’s worth noting that of the 7 reported events that specifically mention MRI’s or X-Rays, 5 occurred well after patients were supposed to have received a letter from the company. According to company officials Medtronic notified the FDA of the issue on April, 19th and began sending out letters on April 24th. The company stated the letter was sent in red envelope that was clearly marked so the patient would not think it was a marketing piece. While the adverse event reports do not disclose the location of where the event occurred Diabetic Investor finds it troubling that events were still occurring as late as June 6th. Equally disturbing is the number of physicians who were unaware of the letter or this issue.
In regards to the field correction/recall issue Diabetic Investor specifically asked the FDA if this situation was a filed correction, the FDA’s spokeswoman stated that this was a Class II recall and NOT a field correction. When asked to clarify the difference between a field correction and a recall the spokeswoman provided the following email response;
“With respect to field corrections, not all recalls necessitate a product being removed from distribution. In many cases, companies will give their direct accounts and consumers information about obtaining replacement parts or supplies that can correct the problem or defective part without removing or exchanging the device. In other cases, a device may be able to be reprogrammed or recalibrated, either directly by the user following the manufacturer’s instructions, or by the manufacturer sending a technician or rep on site to make the correction.”
If this response sounds as if a field correction and a recall are the same thing, get ready to be even more confused. According to the FDA’s web site
A recall is either a correction or a removal depending on where the action takes place.
Correction – Addresses a problem with a medical device in the place where it is used or sold. Removal – Addresses a problem with a medical device by removing it from where it is used or sold.
In fact when Diabetic Investor searched the FDA’s web site for the term “field correction” we could not find any clear definition or explanation of just what a field correction is or when something is classified as a field correction and not a recall. This confusion over terminology is troubling as it does not provide patients or physicians with a clear picture of the seriousness of the problem. To most lay people the term recall means there’s some type of defect and the item should be replaced. On the other hand, correction implies that device does not necessarily need to be replaced and whatever the problem that was identified can be corrected. It also understandable from Medtronic’s point of view why they would prefer this issue should be classified as a field correction rather than a recall.
However this confusion over terminology does not dismiss the fact that Medtronic did a poor job of informing patients and physicians on this issue. Based on information from the FDA’s own database and several interviews conducted by Diabetic Investor it’s obvious that far too many people either did not get the letter or did not comprehend the serious nature of the problem. As we indicated previously there is absolutely no mention of this recall on the MiniMed web site, no instructions on how a patient can run a simple test to determine whether or not their particular pump has been affected. A MiniMed patient would have to type in the term field correction before any reference to the issue is found. While we can’t say for certain Diabetic Investor doubts that the term field correction is in many patients vocabulary.
To Diabetic Investor this situation is just another example of why FDA reforms are desperately needed. Patients and physicians need clear and understandable guidance; this is especially true for insulin pump patients who depend on their device for their survival. As seen by the many reports of hospitalizations or death, pump malfunctions can have serious consequences.
Diabetic Investor is also disturbed by Medtronic’s attempt to minimize this issue. While it is true the FDA does not require a company issue a press release for a Class II recall, there are times when a company for the good of their patients should go beyond FDA guidelines. This is one of those times. In our opinion the company has made matters worse by calling this a field correction when that clearly is not the case. They may not like it but this is recall no matter how they want to spin it. There’s an old saying when it walks like a duck and squawks like a duck – it’s a duck.