The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event, no instrument errors occurred, and the event was limited to patient samples from one patient.Siemens received feedback that the customer did not properly follow the laboratory's policy for handling sample flags.Additionally, pre-analytical issues such as improper sample collection and handling cannot be ruled out.The customer has re-educated the users on proper handling of sample flags.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00064 was also filed for the discordant result obtained on (b)(6) 2020.
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Discordant, falsely elevated and falsely low activated partial thromboplastin time (aptt) results were obtained on three patient samples from the same patient measured on a bcs xp system using actin fsl reagent.Prior to being run on the bcs xp system, each of the samples was run for aptt on a sysmex cs-5100 system.No numerical results were generated on the sysmex cs-5100 system.When run for aptt on the bcs xp system, each of the samples gave a falsely low result with a "doubtful flag" on the first run.On the second run, the first sample gave a falsely low aptt result, the second sample gave a falsely elevated aptt result, and the third sample did not give a numerical result and generated a "curve without reaction" error.On the third run, the first sample gave a falsely elevated aptt result, the second sample gave a falsely low aptt result, and the third sample gave a falsely low aptt result.A falsely low aptt result was reported to the physician(s) who questioned the result.A corrected report was issued but it is unknown which result was reported in the corrected report.Several days later, a new sample from the same patient was measured, recovering acceptably.
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