[2643810]
I guess my complaint is actually one of false advertising. My clinic bought a pronto-7 from (b)(6), to measure hemoglobins percutaneously. It has other functions, but these were not important to us. One of our physicians understood from a salesman at a booth at a conference, that this device's accuracy in measuring hemoglobin was better than a spun hematocrit, though not quite as good as a laboratory venous hemoglobin. We bought one of these based on that presentation. What we didn't notice until later is that the device specifications are that it measures hemoglobin with a standard deviation of 1 gram. I don't know what the standard deviation of a spun hematocrit is officially. It is most dependent on the technique used to obtain the blood, but i would guess from my (b)(6) years of experience that it is 1 or less points of hematocrit, corresponding to less than. 33 points of hemoglobin. So the salesman was totally wrong. The specifications for the device make it clinically useless in measuring hemoglobin. The variation is excessive. One minute the result might show the pt to be anemic, the next to be normal. Comparison from one month to the next - say you'd treated them with iron and wanted to know if they'd gone up by the expected 1g of hemoglobin - would be useless. During the time we have had this device, i am sure that i have sent many pts for anemia or polycythemia workups unnecessarily; i don't know how many pts tested normal at 13 who were really anemic at 11 or less or polycythemic at 13 or more, and so were not appropriately tested and treated. So even if this device worked perfectly to specification the two devices from this company that we have used probably did not live up to specifications, but i have insufficient data to prove that, it is misleading to market it as a device for measuring hemoglobin. I would like the fda to decertify the device for this purpose as i said, the other purposes may work fine. Even without the salesman's lie, their written literature currently states that one should use this device to look for anemia in outpatients. It can not be used for this purpose. This technology is worse than useless, because it gives misleading information and this part of this product should be pulled from the market. If that is impossible, their printed materials should be required to prominently state that the values obtained are plus or minus 2 or 3 grams of hemoglobin so that the clinician can decide whether they have any use for a lab value that varies by 20%. Dates of use: (b)(6) 2011 - (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5