An outside the us customer observed a depressed 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.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 1219913-2022-00021 was filed on january 25, 2022.Additional information - march 14, 2022.An outside the us customer observed a non-reproducible atellica im high sensitivity troponin i (tnih) result from a patient sample compared to repeat results on (b)(6) 2021.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Qc was in range at the time the sample was initially processed.Initial and repeat results are > ifu 99th% cutoff of 45 ng/l.Siemens reviewed system files and found two potential issues: auto check data showed that the secondary vacuum was high and sample traces showed a potential leak in the sample probe.The field service engineer (fse) performed preventive maintenance on the instrument on january 13, 2022 and addressed these issues.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 result on this sample, however, root cause was not identified.There have been no further instances of issues with tnih reported on this system since this escalation (december 31, 2021).No systemic product issue is observed.The customer is operational.In section h6, investigation findings and investigation conclusion codes were updated based on the investigation results.
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