CoaguChek XS 'Urgent Medical Device Correction'

[Protimenow]

I just learned that Roche issued what they call an 'Urgent Medical Device Correction'. I've heard this referred to as a 'recall' -- but it isnt, there's no apparent fix, and the only 'modification' that Roche will apparently make is new instructions in boxes of strips.

Quoting from the 'Correction,' dated 5/16/13, it starts out saying that 'Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an "ERROR 6" message is displayed.'

The document warns that 'If the "ERROR 6" message is displayed repeatedly, use an alternative method to determine an INR result. Patient self-testers are being asked to contact their physician without delay if "ERROR 6" is displayed repeatedly on their meter."

For most of us, this is probably a non-issue, but for patients on chemotherapy or who are taking antibiotics, the "ERROR 6" issue may be a problem. Roche reported that 'only one case of high INR values related to the "ERROR 6" issue has been reported using the CoaguChek XS Meter." This may not be that big a deal, although getting the error message rather than a result can be a problem. Plus, it's important for those on warfarin to be aware that if they get the "ERROR 6" message, they should seek medical assistance.

 

[TheGymGuy]

got the same letter. this is a good PSA.

 

[Freddie]

Can either of you scan and post this letter?

From what I've read this one case happened in Australia:
http://www.pharmacynews.com.au/news/latest-news/roche-recalls-coaguchek-monitors

Then it goes on to say:
Correction: Coagucheck devices not recalled
We wish to alert that our report yesterday may have erroneously implied that Roche had issued a physical recall of CoaguChek monitors. This is not the case.
A spokesperson for Roche said the term “recall” is used by TGA when new important information about a device becomes available and it is appropriate for the users to become aware of it.
“It is a “recall” or a correction of information, not the actual device”.
“The new information we wanted to make known to our customers of an additional (and extremely rare-<0.00015%) reason where they may get an Error 6 on the instrument. This was made very clear in the letter posted to our customers,” the spokesperson said.
We apologise for any confusion...

 

[Protimenow]

I think that I was pretty careful in stating that this wasn't a recall (although the person who sent it to seemed to want to put it into those terms). I looked for a link to this letter when I posted it, so that other users of the XS can see it for themselves. I didn't find the link.

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A more relevant issue, perhaps, than this informational update is the one from a few years ago when some meters gave elevated readings because of the way that the electrodes were cleaned. Roche issued instructions for the proper method of cleaning the strip channel.

My particular meter may be subject to the errors that improper cleaning can produce -- I bought it used. I haven't had the luxury of making actual comparisons to a blood draw, so I don't know if the reason that it reports higher than one of my other meters is because of meter error or some factor in my blood that confuses the meter.