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Old 07-22-2011, 09:33 AM
jamala jamala is offline
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Join Date: Jul 2011
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Default Warning Accu-Chek Mobile high values

"The problems of the Accu-Chek" - report after two days as a student at Roche

I study chemistry in Germany. I had a 'Roche meets' visit for e-fellows (students that could work for Roche - advertising visit) at Roche Diagnostics, Mannheim, Germany. There was an visit through the development of diabetes meters. There, the Accu-Chek devices were developed. First there was the standard program with informatio about career at Roche. There were 1000 Power Point slides shown. Boring. It was the business model. Also, the importance of customers and patients. At the time I still believed that and thought it was great!
Then came the visit through the company. Many offices. A lot of logistics. But little technology.
In Mannheim, it is only the development for diabetes. Otherwise there is nothing more. It does not look for innovation.

The visit went into the development for Accu-Chek boodglucose meters. There is a room with lots of blood glucose meters. They let us try different Accu-Chek: Mobile, Compact, Nano. Since there were important models of meters by other companies. We could only view and not use it. When trying out the Accu-Chek has been with me my blood glucose had a very high value. The woman, who looked after us, said the wrong high values with the measured value is known. There is a problem with the technique. This was recognized in studies. It also had people in the clinic.
She has explanation : When the test strip is beeing pressed or moved, then the value change is different. Because the tape is deformed. Then, the light is measured with the wrong reflected. This also happens when the tape is moved by mistake. Then the dark bars are in the signal. This is a problem with the optical assembly.
As I understand it: the band is like a mirror that reflects the light back to the measuring unit (the red lights within the meter) differently, so that the device detects other, wrong values!
Another flaw: when the finger is not washed, then put any dirt on the tape. This mixes with the blood. This can also give false readings. Man, I should always wash your fingers. I was wondering: what if I'm on a trip? I can not always wash my hands. The answer was: you can not tape over the lead?. But old people get the point no. Not even people with low blood sugar. Or on the bus, if it wobbles.

The high values are also known by other users. In many forums it is reported. But the company does not care. The woman was delighted by the mechanical standard in Mobile. But what brings people with diabetes complicated technology, if not the result of sugar right? As developed by false pretenses!
A member of the development says, for admission in the clinical study were were cassettes pre-selected, pre-sorted. To make sure nothing happens! That said!!!

The employees also said that the new system, the successor of Mobile, there should be only better technology. Bluetooth, USB and so on. But to measure the volume and the type remains the same!
The error remains!
It does not get better, and Roche agrees that the wrong people measure.

It went on. In a laboratory. The people of the development in the narrow laboratory looked annoyed when we were out there. The measure thousand strips by hand every day. I asked a woman in a yellow shirt Whether the false with the values often occur? As pushed in between the lab director and said we need to leave the room because of risk of infection.

That was an interesting first day. I was very shocked? About the openness of me? Found was about? HAZARDOUS bug speak!

On days at most a man by the way said, that Roche is developing a whole new system:
Arbeutet it with a new chemistry, which is insensitive to light and humidity. It was measured with UV. It should be as small lancets. Over a small canal, the blood comes automatically to the test area. It takes very little blood volume for 50 or more tests ona disk. It is a technical gimmick, a TOY - too fragile for each day measuring.
After what I've learned the day before this is still found as dangerous: The diabetic has no more influence on the measurement. The lower the blood volume, the sensitive system to dirt! Then again tinkered a technical gimmick. And diabetics, Roche does not matter.
About Facebook, I am in contact with one of the developers. It CONFIRMS my suspicions and says that Roche is no longer Boehringer. It would be saved. There are degraded places. The quality is t low.

The high-bay warehouse was the only technical highlight of the day. There was something to see what was modern times. It has surprised me? How easy everything was for Roche and how dreary and gray.

Known problems as to turn that it is sold is still not great.

Need a FDA warning letter: Accu-Chek Mobile High Values Bloodglucose Wrong Values!
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