Model Number ADVIA CENTAUR XP |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The customer contacted the siemens customer care center (ccc) due to quality control (qc) out of range on multiple assays.A siemens customer service engineer (cse) was dispatched to the customer's site.After inspecting all dispenses and aspirations at the wash manifold, the cse observed aspirate probe 1 not aspirating properly.The cse inspected pinch valve and tubing.The cse found that aspirate probe 1 tubing had a break and replaced it.The cse performed empty and fill cuvettes.The cse ran qc, resulting satisfactory.The cause of this issue was the split aspirate tube.The instrument is performing according to specifications.No further evaluation of the device is required.
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Event Description
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Discordant falsely elevated prostate specific antigen (psa) results were obtained on two patient samples on an advia centaur xp instrument.The discordant results were reported to the physician(s).The samples were repeated on the same instrument two days later post service, resulting lower.The corrected results were reported to physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated psa results.
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Search Alerts/Recalls
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