CoaguChek S & Roche Diagnostics

[rws]

Seems as if the rules changed after I was approved to purchase their meter and test strips. Medical supply companies are cracking down, (under pressure from Roche) and will no longer sell me test strips since I am not a professional office etc? I talked to Roche today and they claim the S meter was never approved for home use. Five years ago my medical office offered training and a script so I could purchase the CoaguChek S from a Roche distributor. Roche claims that never should have happened. Anyone else caught up in this ?

 

[Ross]

I haven't, but wonder if they'd answer the question as to why it's only approved for medical professionals and not patient use?

Maybe somewhere in all this mess you can find something:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=864

And since it did in fact happen, what are they going to do to make sure you can test? I would think they should offer you the XS system in exchange for free.

 

[Bina]

I know the rules are sometimes different for Canada.....but in June 2007 when I ordered my machine and strips I was automatically offered the new XS which was delivered to a nearby pharmacy where I could receive my instruction and pay for the machine and kit. Since it is a prescription item, Roche were not permitted to send it to me personally.

 

[netmiff]

Same here as Bina, only wanted to add that the pharmacist here has to be a certified CoaguChek trainer . . NOT an anti-coagulation specialist like Al, but approved by Roche to train on Coaguchek use.

 

[lance]

RWS
This subject came up some time ago when "S" users posted difficulties obtaining strips. So I contacted Roche (Canada) to be told the FDA had not approved them for "home use". Instead of advising users up front Roche evaded the issue saying strips would be available at a certain time--a month or two. I was using an "XS" and the pharmacy ordered "S" strips by mistake so I knew they were available. Hopefully Roche will offer a replacement to you at a reduced price. My experience with them has been extremely positive.

Netmiff,

I was lucky and was trained at the TGH in Toronto to use both my monitors. When the training was completed I was qualified to train others. No doubt I would be the worst teacher in history so I never had the paperwork put through. The XS is simple to use and my spouse trained himself by watching me. Funny how things work out.

Hi Bina,

You were lucky the pharmacist was qualified and you didn't have to travel very far. I'm the only home tester in this area so I don't think there is a great need for trained pharmacists yet. The situation my change IF POC monitors are funded by Health Canada. Hopefully they will be allowing more patient access to this fabulous technology.

 

[ShezaGirlie]

Info

Info

The original CoaguChek circa 1999 uses the same strips as the CoaguChek S machine. I don't know about the XS.....don't have one of those yet.

 

[rws]

If I am to believe Roche I was sold a CLIA-waived device for professional use only with one of their distributors clearly knowing it was sold for home use. In fact, I have emails from 2002 instructing me how to qualify and purchase for home use. I also have the receipt noting my script. Bottom line I was illegally (according to Roche) sold the meter by one of their distributors, not to mention test strips for the past five years. According to my clinic I am far from the only patient owning an S model meter for home use. I am waiting to hear back from the medical supply that sold me the meter. I will pursue this to resolve, I should not have to take a $1400.00 hit because I was incorrectly sold the S meter....we shall see....

 

[Ross]

Maybe mention attorney during the conversation with them and see where it goes from there?

 

[escargome]

I agree with Ross. Mention attorney cause I would think that Roche would be trying to kiss your toes right now. Selling a product registered for professional use to a patient for home use is "misbranding" as the FDA looks at it.

 

[Mufi]

Things are very different here in the UK. Roach swapped my old model (not sure which one) for the S model free of charge in 1999 (I think) At that time I had to buy the strips myself, but a few years ago the NHS finally allowed these to be dispensed on prescription. The problem now is that the S is no longer in production, though there seems to be no problem here getting the strips. However, yesterday my machine developed a fault and after ringing the Roach help line I was told that as the S is no longer made it can not be repaired, but not to worry because they would sell me one at the full retail price of £399.

I think they are telling "porkies" about the S not being ok for home use. It was certainly sold to me originally on that basis.

If you own this model keep fingers crossed that it keeps working, because if it goes chips you will have to dustbin it like mine.

David.

 

[Eva]

Mentioning an attorney will definitely make them send you a replacement for free...and it makes sense...legally they should!