[17429464]
Md feels that the testing device is not accurate in the readings it gives since it takes too long for the urine being tested to go through the filtering system. The labeling of the device does not specify that this could occur if it takes longer to filter the specimen. According to the instructions, it should take 10 to 15 secs for the mixture to pass completely through the filter. In md's experience, the mixture has never completely passed through the filter in 10 to 15 secs. The mixture has never passed through the filter in less than 60 secs and usually took a number of mins. At some point, md contacted mfr about this issue, who suggested a number of techniques not contained in the product directions to help decrease the amount of time it was taking for the mixture to drain. None of the mfr's suggestions resulted in any decrease in filtration time. After a number of discussions and after pressing the mfr on the issue, they conceded that time was critical to the accuracy of the product and that if the mixture did not completely pass through the filter in 10-15 secs, the test results would not be accurate. The first complaint by the consumer is that the product does not work as advertised. Second, the product instructions are inadequate. Nowhere in the instructions does the mfr disclose that accuracy cannot be obtained if the mixture does not drain in the 10-15 sec time period. Based upon md's experience, the product is defective, either because of a design defect, inadequate instructions, or both.
Patient Sequence No: 1, Text Type: D, B5