An outside the us customer observed depressed atellica im high-sensitivity troponin i (tnih) results from two samples that were considered discordant on comparison with the other results from the same samples.Interpretation of results of the instructions for use (ifu) states the following: " results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
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The initial mdr 1219913-2022-00020 was filed on january 25, 2022.Additional information - march 7, 2022.An outside the us customer observed an elevated atellica im high-sensitivity troponin i (tnih) result from a sample that was considered discordant on comparison with the other results from the same sample.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Qc was in range at the time the samples were initially run.Initial and repeat results were all elevated above the ifu 99th% cutoff of 45 ng/l and were not clinically discordant.Siemens reviewed this event from a hardware perspective and noticed two potential hardware issues.Auto check data showed that the secondary vacuum was high, and sample traces showed that there was a potential leak in the sample probe.A customer service engineer (cse) performed service to the instrument.Trace records post service were not available for review.Siemens cannot rule out the above system issues as the potential root cause of the discordant tnih results on this event, however, root cause was not identified.There have been no further instances of issues with tnih reported on this system since december 31, 2021.No systemic product issue is observed.The customer is operational.No further action is needed.
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