Coaguchek - Roche

  1. Anyone out there using the Coaguchek for point of care INR testing? What are you doing about the FDA alert?
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  2. 11 Comments

  3. by   rehab nurse
    i can't remember the name of the one we use at work, but it is like a large glucometer. works exactly the same, only you have to siphon the blood from the fingerstick in the tube and drop it on the stick. it can be kinda tricky sometimes, but overall it saves us a lot of money in lab fees.

    at first, we also did lab draws along with the coagucheck to see how results averaged. they were pretty close, and we have overall been pretty pleased with it. it does have some complicated starting up procedures, but it does come with a nice book that takes you through it step by step.

    since there are so many pts of ours needing INR's, it's been a godsend.

    not sure this is what you were looking for, but just wanted to chime in!
  4. by   UM Review RN
    We use iStat. Is this the machine having a problem?
  5. by   anticoagulationurse
    The machine (actually unidentified lots of the test strips used in the machine) in question is the Coaguchek S from Roche. I don't know if there are problems with any of the other coagulation monitors out there... But Roche is suggesting duplicate testing with different lot numbers for each patient getting a Point of Care INR with the machine. Out of 60 or so tests since the "Product Alert" was issued and enforced by the FDA last week, only 2 had the same result between lot numbers.

    Roche provided paramaters for when to send the patient to the lab for a confirmation of the INR, and none of the results have been outside that range. Even with discrepancies as high as 29% between two lot numbers. The range seems dangerously generous to me. For example, an INR result of 3.0 on one lot of test strips and 3.9 on another lot of test strips on the same patient at the same time would be within the acceptable range of discrepancy. Or worse, if one lot number reports 1.6 and the other 2.0, this is within acceptable discrepancy margins as well.

    Coumadin dose adjustments are based on the results! The protocols where I work indicate to change the Coumadin dose by a certain percentage for an INR of 1.6 or 3.9 (or anything out of range). But, according to Roche, these results are acceptable? It just concerns me, and if I was a patient on Coumadin I would not be getting a fingerstick right now! I'd be going to the lab for an old fashioned veni-puncture.

    Just wondering what others using the Coaguchek are doing. And if you think I am being too stringent. Thanks.
  6. by   rehab nurse
    hey,

    just went online to check and see if this is the POC system we use, and it is.

    now, at my work, we have short term patients, usually from 1 week to 3 weeks at most. so, we pull the records from the hospital and try to track the trends with dosing.

    some people react so sensitive to the coumadin, and i don't feel safe with that either. however, we have also had severe discrepencies with our own lab. once, i had to send a pt out for INR of 8.6 (repeated twice by seperate sticks). went to hospital, pt came right back with their lab stating it was only 5.6 and they received some Vit K. i couldn't believe it!!

    i don't see any issue of this FDA alert at work either. however, since the last nurse who opened the box didn't reorder, we are doing all the INR's by lab draws anyway. just as well to draw another tube if you're drawing a rainbow anyway

    do you have a link to the FDA alert?? i know we've had this issue come up before with issues with certain lot numbers. docs always just made us draw instead.

    sorry couldn't be more help, but wanted to say we've gone through it too.
  7. by   anticoagulationurse
    Here is the product alert link supplied by Roche. I also checked out the one the FDA has issued and the content/information is the same. There are 2 alerts issued 10/19/06; one for product alert and another for suggested duplicate testing parameters (those are the ones we are using and I am not comfortable with).

    http://www.coaguchek-usa.com/product...ion/index.html
  8. by   gigi1980
    Yes, we use it in the family medicine office where I am the nursing supervisor. After reviewing the letter and talking to a Roche rep, our clinical providers and I decided to stop using it for now until further notice from Roche.

    Eventhough there will be reimbursement for the duplicate testing, it is still costly for the office.

    PSS, our supplier, is offering the buy one box and get a box free, however, the cannot guarantee that it will be two different lots.

    There is too much of a chance of a significant gap between the two results. The patient would still end up being sent to the lab for a confirmation PT/INR anyway.

    Our office always keeps a log of all of the results and review them on a monthly basis. Recently, during one of the reviews, everyone noticed that over the past 3 months, there had been an increase in the amount of patients that had higher INRs than expected that were followed up with lab draws that showed a 3 or greater difference between the results. Controls were all within norm, so it was contributed to tech error.

    Our doctors run their own coag clinic and base the patients Coumadin off of the results. Our practice is fortunate to have a satellite lab in the same building, so our patients are now being sent to the lab for all PT/INRs and the results come back to the office within 24 hours. This will continue until further notification from Roche.
  9. by   prowlingMA
    We are having this problem in our office. For now we are checking every pt with two machines. Which it is hard enough to get one " good" reading with these machines. They are bulky, you can't touch the machine while testing or it errors, and it requires a lot of blood. Many times we gove up and draw periferal blood to check. I hope we throw these out and get new ones very soon. Just my rant on INR's.
  10. by   willow54
    We are currently using 2 Coaguchek machines with 2 different lot #'s of strips. Most of our patients prefer a venuos stick so there is not a problem getting enough blood. I am amazed at the acceptable range of discrepancy.
    We just got a new ProTime machine and will start using it as soon as these strips are gone.
  11. by   DutchgirlRN
    We have the PT/INR machines in the HH office. I always do venipuncture. I've never had a patient complain. The other nurses all use the machines. Patients haven't even asked why I'm doing venipuncture. I feel more comfortable with venipuncture results. The machines are good for screening to see if it's really high other than that I don't like them.
  12. by   jtagle
    Hello. Currently we are considering purchasing ProTime to replace the Coaguchek. Can anyone give me any insights on your experience with both machines? What is your experience with the ProTime machine? Thank you!
  13. by   jtagle
    Quote from willow54
    We are currently using 2 Coaguchek machines with 2 different lot #'s of strips. Most of our patients prefer a venuos stick so there is not a problem getting enough blood. I am amazed at the acceptable range of discrepancy.
    We just got a new ProTime machine and will start using it as soon as these strips are gone.
    How has the ProTime machine purchased worked? Thank you!

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