The cs-5100 instructions for use (ifu) chapter 3- principles of operation describes assessment flags that are displayed with analysis results.An asterisk [*] means that the result is of low-reliability.The [***.*] symbol means analysis results could not be obtained due to errors and other problems.All analyses, with the exception of the analysis performed on 03/16/2020, generated assessment flags indicating errors occurred or low-reliability of results."no coagulation" and "slight coagulation" errors were generated.Chapter 7 - troubleshooting, displays the various producible errors, and the meanings associated with the errors.The probable cause for the "no coagulation" error indicates the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or reagent problem.To resolve the error, the user is to repeat the analysis and make an overall judgement of the sample and reagents.The probable cause for the "slight coagulation" error indicates the detected coagulation reaction was extremely weak, due to a sample with low fibrinogen concentration or due to a problem with the sample or reagent.To resolve the error, the user is to check the volume of the sample and reagent then repeat the analysis.For fibrinogen analysis, change the dilution ratio of the sample before repeating.Further verification of results is recommend prior to result reporting.The cs-5100 application sheet for fibrinogen with dade thrombin reagent: limitations of the procedure, provides the threshold concentration of interfering substances.Bilirubin concentrations up to 6 mg/dl will not interfere with the assay.The patient's bilirubin concentration was reported to be approximately 50 mg/dl, which exceeds the interfering substance threshold concentration.No product deficiency was identified.
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