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Summary of events for malfunctioning/erroneous results from coaguchek xs system.My mother (b)(6) has been using the coaguchek xs system to check her inr level since late 2008 after her valve replacement and stints and pacemaker insertion.We have relied on these results to monitor the amount of warfarin she takes.She has always been prescribed 1 mg warfarin once a day.Until (b)(6) 2016 we have never felt there was a problem with the device or had any reason to suspect a problem.On (b)(6) 2016 my mother fell and broke her hip and had to have emergency surgery to repair the broken hip on (b)(6).To prepare for the surgery she was given vitamin k to bring her inr level down to regular levels in order to have surgery.She had to remain off of her warfarin for a few days.While in the hospital she was given lovenox injections to prevent blood clots for a few days.After leaving the hospital she was sent to a skilled nursing facility for physical rehabilitation therapy.Her medications were monitored closely as was her warfarin.Daily venous draws were done to monitor her inr levels.She was removed from warfarin on wednesday (b)(6) due to a high level.My mother was released from the nursing facility on friday (b)(6).After arriving home the nursing facility called and told us that her morning inr reading was a 5.1 (too high).I notified her cardiologist's office and was told to test her with her coaguchek unit on saturday (b)(6) and if the reading was high to take her to the er.I tested her at 8:50 am on saturday (b)(6) and her reading was a 6.2 on her right finger.Immediately called her cardiology nurse and she told me to take her to the er.In the er blood was drawn venous at 1:15 pm.That reading came back at 2:50 pm as a 4.4.There is no way that this reading could drop from 6.2 to 4.4 in the matter of an hour and a half without any assistance.So i told the er doctor let me check her again with the coaguchek meter and we performed the test in the hospital.At 2:55 pm i did another right finger stick and the reading was a 6.4! now how can there be that much of a difference? immediately called the roche industries telephone number on the back of the meter to report the problem.I was told that a fda case report was being filled out and that they would immediately send me out a new meter in case the current meter we had was malfunctioning and they would get back in touch with me to finish the report.At 4:55 pm when we arrived home i opened a new bottle of test strips and ran the test again using the left finger.Result 6.2.On sunday (b)(6) my mother's home health nurse with (b)(6) home health came to see her at home.She also uses the coaguchek xs system and just received a new unit within the past month.She tested my mother at 1:30 pm with a right finger stick.The reading was 5.8.I immediately tested her with our meter on the left finger and the reading was a 6.5.Once again why such a variance with now 2 different meters.The home health nurse tested her with her meter before she left at 2:30 on her left finger and the results a 6.0 up 2/10th from 5.8 an hour before.This is a disturbing problem at this point.We were already scheduled for a recheck on monday (b)(6) at the hospital for another venous draw.This was done at 9:40 am at (b)(6) hospital.The result was a 4.3.There is no way that any of the readings the day before with the coaguchek meter were anywhere near correct.My mother's new meter arrived from roche on monday (b)(6).On wednesday (b)(6) my mother went back to the hospital for another vein draw inr done at 9:30 am.Her reading was 3.4.At 10:30 am when we arrived home from the hospital testing i used my mother's new coaguchek unit and tested her and the result was a reading of 4.0.Only 6/10th off now.I have since spoken with (b)(4) at roche industries at (b)(4) who is handling this case and explained all of the above to her.It seemed as if she wasn't concerned about any other meter but the original one.Finally she said to me that "there must be a problem with your mother's blood that she is testing that much off".The statement highly upsets me because we depend on this meter to be accurate to prevent my mother from having blood clots.She also said there is expected to be some variance in the readings compared to vein draws.I along with the nurse from the home health company are very disturbed by these events.The home health nurse is making life saving decisions whether or not to withhold blood thinners based on the readings coming from a meter that is giving erroneous results.If she withholds thinners based on a reading that may be too high (and it's an error) her client could develop a blood clot that could result in a life threatening outcome.The nurse has discontinued using her meter and has notified her company of the problem.This also has happened with 3 separate meters and not just 1.Someone needs to start testing these units to determine if a problem has begun.Don't just depend on the manufacturer to self regulate because the public's health and lives are at stake.
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