A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse discovered bleach in the system.The cse replaced the bleach valves.The cse also installed a new base probe and pump, replaced the base bottle straw, ionizer, and probe, and changed the acid and base lines.There were no discordant troponin results after service was performed.The cause of the discordant troponin result is unknown.
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The initial mdr 2432235-2014-00745 was filed on december 29, 2014.Additional information (01/08/2015): a siemens customer service engineer (cse) and a siemens technical application specialist (tas) revisited the customer site.After evaluation of the instrument, the tas decontaminated the acid, base, wash 1 solution, and water lines.The tas then ran multiple replicates of multi-diluent, negative quality control (qc) material, and a patient pool and discovered that qc precision was out of specification and two patient values were incorrect.The cse replaced the wash manifold and then the tas repeated qc and the patient pool, obtaining an acceptable coefficient of variation (%cv).The cause of the discordant, falsely elevated troponin result was related to a malfunction of the wash manifold.Additional information (01/23/2015): no additional discordant troponin results have been obtained on the instrument.The instrument is performing according to specifications.No further evaluation of this device is required.
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