Roche CoaguChek conspiracy?

[LUVMyBirman]

After 2 hours of holding! Finally an answer. One faulty strip caused the recall. Internal quality control @ Roche. In turn they decided to recall them all. Don't really understand the rational behind it. Strips have been recalled before...by lot. Not every single strip out there! Oh...and I hear the new XS unit should be available to patients sometime in January. Interesting to say the least. Wonder if all this is going to overlap! In the meantime...off to the vampire bats we go

 

[DrAllan]

Clicker Ticker and others

This is my personal opinion as a physician and chemist. Roche has not said what percentage of strips are defective. it appears that this crosses lot lines as well. There letter to the FDA specifically says for home testers are not to use any strips at all. For clinical testers such as doctors's offices and clinics such as run by Al, they recomend testing with a second strip from another lot number is possible if the opriginal reading is spuriously high.
I am having difficulty on the basis of this info trying to elucidate the degree and nature of the problem. There should be a straight forward epidemiolgical explanation. It seems to me that Roche (forgetting the conspiracy theories origianly proposed is taking the high road by the total recall. For any of you who have had problems with Guidant ICD devices where the company lied and continued to sell defective units, the comparisons are obvious. At this point with the info at hand I congradulate Roche.

I will not pubically state as to what degree I am going to mix lab draws with remaining strips. My problem is that I was four days ago placed on medications that increease the INR. i want to be damn sure that what happens and drug changes is a drug effect not defective strips.

Again to go back to the ICD question. Medtronic was up front with their recall as oppposed to Guidant. Both reimbursed patients for expenses beyond their covered medical costs. I wonder if Roche will pay transportation etc. costs beyond replacing the strips?

Best to you,

Allan

 

[Blanche]

I have been waiting for the new CoaguChek to be approved. Now, based on the information provided by users of the INRatio monitor, we will be ordering that monitor within the month.

What concerns me most about this recall is the fall-out this will have for those who wish to purchase home testers, especially if they have "timerous" doctors. This recall is going to call into question the safety of the CoaguChek and all other in home monitors.

People here on this board were pioneers who helped so many of us convince our doubting doctors that home testing was valid and realible. Now, I fear that all the old doubts will once again surface. I can already hear the Cardio's phlebotomist say, " Didn't I tell you time and time again that those testers were no good. See, I warned you." It's very sad.

Blanche

 

[Granbonny]

I am going to call my Cardio's nurse tomorrow and ask her. What do yall use for INR'S?..She is a good friend. call my INR to her every month..Been doing that for 4 years..4 months now...she always calls back the same day. I notice when I am in their office for my 6 month checkup..50% of the people in waiting room is there for their range..taking coumadin....She/ and My Cardio love my hometesting.Protime..Bonnie

 

[LUVMyBirman]

Wish I even had that option Bonnie. Finger test in the office. We have state of the art everything around here. No Coumadin clinic. Can't beleive it. Not sure what I will be doing.

I play this over and over in my head. Just does not add up. Why would they recall all of the strips for one bad strip? Then they can't tell us when they will release more. I asked how long will it take? Weeks, months, years? They could not answer me. I still think this new little XS unit will become available before strips do.

 

[LUVMyBirman]

Blance....my rebuttal would be....if the units were that "far off the mark"....how come you all still use them to test us in the office?

Boy....I will fight this one tooth and nail. After almost 8 years....think I have earned it. How long has the INR ratio been available? How close does the unit come to the lab in comparsions?

Will give Roche 2 weeks. If I can't get a release date for the strips. Guess I will be looking elsewhere. Maybe that is what Roche is trying to achieve? Tossing out the home tester for good. Ok, off my soapbox. Don't have time to waste on this subject

 

[Guest]

They recalled them all because if something happened with another one everyone would jump on them saying, "You knew you had a problem, why didn't you take the necessary steps to be certain that nobody was harmed?"

The only person who would be happy if something like that happened would be ex-congressman Foley - because the media would finally forget about him.

As for doctors being worried about home testing, they place so much faith in hospital labs that nobody even wondered about St. Agnes Hospital in Philadelphia getting 900 some wrong readings and killing two people. It was a patient that finally questioned why they were needing so many dosage changes after being stable for so long that tipped a doctor off to the problem. A lab person had not keyed in the correct lot number so the tester was calculating a faulty INR. The fingerstick machines do it automatically as a fail-safe mode.

 

[DrAllan]

Al,

Your statement as to the hospital not keying in the correct lot number (St. Agnes Hospital in Philadelphia getting 900 some wrong readings and killing two people.) and the effects are at odds with the Roche press release of which I have copied the first paragraph:

FOR IMMEDIATE RELEASE -- October 19, 2006 -- Roche Diagnostics is notifying users of an important recall of all CoaguChek® PT test strips currently in the market, due to a potential for a test strip defect that may cause falsely elevated test results. The company has identified the root cause and is instituting corrective action with highest priority. To date, the company has confirmed one incident and its internal investigation suggests that a small percentage of strips may be affected. To date, no deaths, illnesses or injuries have been reported due to this issue.

As you have pointed out the home machines require the insertion of the chip, which programs the appropriate data.

Does anyone know the real truth about what is going on?

 

[ClickerTicker]

Current situation in UK

Current situation in UK

I spoke at some length today with the Tech Support department at Roche UK. This issue seems to have surprised them just about as much as it has us.
They are currently working on a statement, backed up by press advertising etc. It's hoped to be within a week or so, but is dependent upon agreement from the regulatory agencies in UK and Eire.

Current plans (not confirmed) are to ask UK home testers to test twice - each with a different lot number on the strips. A box of strips with a different lot number to our own will be mailed to us free of charge.

This seems to me to be good news if approved by the regulators. The ratio of defective strips to good ones is thought to be in the order of one in ten thousand. Those odds seem pretty good to me, even without a double-test.

I also queried the new Coaguchek XS model - this uses a different manufacturing process and is not affected.

 

[Blanche]

St Agnes Hospital errors and deaths

St Agnes Hospital errors and deaths

I remember the problems with St. Agnes Hospital. Our doctor read about it and wanted Al to stop using his home tester. More than 900 people had problems and two people died. There was an interesting thread about this when it happened. I am leaving the link for those who are interested.

http://www.valvereplacement.com/forums/showthread.php?t=415&highlight=Agnes+Hospital

Blanche

 

[Emma]

Thankyou for doing that!!

xxxx

I spoke at some length today with the Tech Support department at Roche UK. This issue seems to have surprised them just about as much as it has us.
They are currently working on a statement, backed up by press advertising etc. It's hoped to be within a week or so, but is dependent upon agreement from the regulatory agencies in UK and Eire.

Current plans (not confirmed) are to ask UK home testers to test twice - each with a different lot number on the strips. A box of strips with a different lot number to our own will be mailed to us free of charge.

This seems to me to be good news if approved by the regulators. The ratio of defective strips to good ones is thought to be in the order of one in ten thousand. Those odds seem pretty good to me, even without a double-test.

I also queried the new Coaguchek XS model - this uses a different manufacturing process and is not affected.

 

[doyo]

CoaguChek XS approved for Professional Use only

CoaguChek XS approved for Professional Use only

Hi Al,

Your post is the reality that is really concerning. Never thought of the trickling effect. Hospital's and labs being backed up. If that will be the case...looks like I will be purchasing another brand of home tester. Will contact my ins co. tomorrow to CYA. This could be catastrophic for the business of Roche. It's a shame because their product has been superior.

PS...on the Coaguchek XS. Has is been approved for the patient?

Gina,
According to the info. I received from Roche about a month ago, CoaguChek XS is FDA approved for only the professional use.
They plan to release it to the professional market (such as Al's clinic) in 1Q 2007. They gave no date for additional FDA approval for home users and the subsequent release date to patient (pun intended) users like us
Based on this date, the S strip will be available before XS machine...

The conspiracy on Roche's part seems unlikely because people will end up buying ITC Protime or InRatio instead of waiting forever for XS like Blanche has decided.

It is unfortunate that this happened with S strip. Maybe you can get your doctor's help in obtaining XS when it comes out early next year if that is what you'd like to do...

 

[ClickerTicker]

Actually there's also an "XS Plus" that looks to be aimed at clinics like Al's...
http://www.roche-diagnostics.com/products_services/productfamily.html?productfamily=CoaguChek%20system

 

[LUVMyBirman]

Roche and Tapistry Medical both claim the XS should be released to patients in the US early next year.

This is such a mess! Mentioned in a earlier post...if we can't get an ETA on the current strips within a few weeks. I will be purchasing myself an nice new INR Ratio. Be done with it!

Anyone aware of the turn around time? Start to finish when purchasing a INR Ratio. Maybe I should be contacting QAS!

 

[Karlynn]

I'd contact QAS, and at least let them get the ball rolling. Should you end up waiting and getting the new XS, at least some of the paperwork will be done. If the INRatio is just a short turnaround time, I do think you'd be very happy with it. I love mine.

 

[Guest]

Thee is no gruarantee that the same thing (or something similar) will not happen to the other companies in the future.

 

[LUVMyBirman]

Thank you Karlynn. So happy you like yours.

Al, yes....I do understand your point.

 

[fyrfytr]

Hey Gina,
That is what I did. When I contacted QAS about this last Friday I went ahead and had them start the paperwork for the INRatio. I also was looking forward to the new XS.

 

[LUVMyBirman]

Thanks Dave. Think I will do the same. Did they inform you of how quickly they could turn it around for you? Will give Lance a ring when he returns from his cruise

 

[fyrfytr]

Hey Gina,
I talked to Joyce at QAS and she said when they get the paperwork back from the Dr. it should be about 10 days. I called by Dr. and told them the paperwork would be coming. So I hope the INRatio will be coming by the end of next week. I don't think I will hold my breath though.