Arkray's investigation determined the cause to be software related, not hardware.A scar was issued to the software developer (sysmex) for corrective action.Sysmex identified that this issue was caused by an incorrect shut down by users after analyzing the software and the log of the instrument.Sysmex is working on a software update to prevent this issue even if the user error occurs.When we initially received the complaint, it wasn't judged to be serious, however, our judgment for seriousness was changed by the subsequent investigation result and additional information.Accordingly, we have decided to file an mdr.Original incident was reported in february (9611444-2019-00002), however since filing, we received clarification there were two additional patients involved.Filing 1 of 2 additional patients with this mdr.
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