Discordant, falsely elevated troponin ultra (tni ul) results were obtained on one patient sample on an advia centaur xp instrument.The patient sample was initially run in triplicate and the first two replicates resulted high, then the third replicate resulted lower.The same sample was then repeated on the same instrument and another advia centaur system, resulting lower on both.The falsely elevated results were not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant tni ultra results.
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Siemens filed initial mdr 2432235-2014-00473 on 13-aug-2014 and a follow up/supplemental report with mfr report # 2432253-2014-00473 on 10-oct-2014.Correction (12-dec-2019): the mfr report # for the follow up/supplemental report should have been 2432235-2014-00473.The mfr report # was updated to reflect this information.The information documented in the follow up/supplemental report submitted on 10-oct-2014 can be found below: siemens filed the initial mdr 2432253-2014-00473 on august 13, 2014.Additional information (09/17/2014): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data and troubleshooting troponin imprecision, the cse replaced the ancillary probe, ancillary plunger, aspirate probe 1 pinch valve, aspirate probe 2 pinch valve, index mechanism, servo motor, servo processing computer board low level controller, ionizer and the incubation ring.The cse cleaned the pinch valve 2 power connector due a buildup of corrosion and performed system decontamination.The cause for the discordant troponin results is unknown.The instrument is operational and performing within specifications.No further investigation is required.
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