Siemens healthcare diagnostics inc.(siemens) analyzed sysmex cs-5100 system backup files provided by the customer to determine the cause of the discordant, falsely low aptt results on the sysmex cs-5100 system.Siemens did not identify any systemic issues with the sysmex cs-5100 system.The cause of the event is unknown.The instrument and reagents are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2017-00083, mdr 9610806-2017-00084, mdr 9610806-2017-00085, and mdr 9610806-2017-00087 were filed for the same event.
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Two discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on a patient sample on the sysmex cs-5100 system.One result was obtained by mixing a test in a one-to-one dilution with the patient sample and the other was obtained by adding polybrene.These results were reported to the physician and it is unknown whether the physician questioned these results.On (b)(6) 2017, correct aptt results from other samples of the same patient were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results.
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