Running controls, Coaguchek

[LUVMyBirman]

Was wondering if any of you using the Coaguchek have had out of range control readings?

Don't need to pay close attention to control#1 'white control' as I calibrate against the 'blue' #2 control for my Mitral valve ranges.

Question....my unit checks out fine next to the lab.
My #1 control is out of range. #2 control was within range, but upper limits.

Confused

I really should call Roche and send it off for service, but I don't want to let it go

 

[Guest]

There is an 800 number to call 24/7. Tell them you want a new one shipped to you before you send this one back. I think they will even send you a FedEx sticker and you can send it in the same box the new one came in. They may want your credit card info but have them agree not to bill it unless it is not back to them with a week or so. I think they will do all of this anyway whether you ask or not.

 

[Marty]

Control out of range?

Control out of range?

No, Gina, in over three years I have never had a conrol close to being out of range. If I did I would call Roche for help.

 

[LUVMyBirman]

Hi Al and Marty

Thank you for your responses. Will take Al's advice and handle it accordingly. What is baffling......I am still within .02 of my doctors lab??

My main concern is that they will not be able to replace my unit. Are they still making the Coaguchek#1?

 

[Marty]

Coagucheks

Coagucheks

Yes Gina, I talked to Roche about three months ago
and they are still making the old coagucheks for Drs offices and labs. They intend to sell to individuals again soon and will have to sell the old Coaguchek since it has already passed all the FDA tests. The S has not gone through testing yet.

 

[LUVMyBirman]

Interesting Marty, so you are saying the FDA has not approved the S?

I am happy to learn that Roche has come around and will be selling to individuals again. There is such a vast need for this type of management. Also, I am a bit less nervous knowing we can easily obtain a replacement if something happens to our unit!

PS. How is Alice doing? Send me a PM when you have a moment.

 

[Guest]

I think what Marty meant was that the CoaguChek S has not been CLIA waived. The Clinical Laboratory Improvement Act waiver is important for sales to the public because it eliminates a lot of training.

 

[LUVMyBirman]

Hi Al and Marty

Well, it turns out my Coaguchek fizzeled out.
Roche sent me new strips and controls and my ranges were still off. We left it at that over the weekend and today when I tested myself.....my INR was riding low 2.2, got real concerned and went in for a stat test at the hospital.
Lab 2.7. Brought my unit with and tested simultaneously.
They will send me a new unit, but in the last breath said.....
"well it's probably your technique not the unit". My response....my technique worked just fine for a year All of a sudden, three boxes of strips and controls later I am still having problems matching the lab and controls are out of range????

As you can tell I am a little hot under the collar at the moment.

Thanks for listening.

 

[Rick W]

Hi Gina. Just to let you know when a control is out of range the results are considered invalid. Period. When faced with this situation in a lab my first action is toss the control and make a new one, then re-test it. Next thing is to question the reagents or the instrument, which is exactly what you did. If you happen to match a lab result when your controls are out means one of two things.1) your controls are bad or 2) just dumb luck. Your technique is fine as you indicated and comparing results with a lab when results are in question are proper actions on your part. Additionally, two controls MUST be in range in order to accept results. If one is out it puts the second one in question.
I hope this helps you.

Rick
CLS,ASCP

 

[LUVMyBirman]

Hi Rick

Really appreciate your professional opinion. Thank you.
Roche was fast to accept my unit was working properly with only one control out of 6 coming within range. And, at the upper limits of range at that.

After testing with the lab today and seeing the .05 difference.....I finally said you all could be compromising my health at the expense of a $1500 unit. I have been running in circles over this for almost a month.

Checked the reliability of the unit and it comes in with proper results 96% of the time. Like you said, just dumb luck that I got a lemon, or should I rephrase and say it malfunctioned after using it for a year.

All in all I feel it is still a good unit. Appreciate the convenience. It just boils down to vigilance in our testing, comparing and controls.

Thanks again.

 

[Guest]

Different labs use different methods and reagents. This is why the PT cannot be used for warfarin monitoring. The INR accounts for differences in the PT from using different techniques.

Anyone being monitored by PTs is receiving substandard care that is at least 12 years out of date.

A technician failing to enter the sensitivity information is wahta accounted for the disaster at St. Agnes Hospital in Philadelphia last year. This is where the home monitors are superior, they use a chip which must match or the test will not run.