Siemens healthcare diagnostics inc.Filed the initial mdr 2432235-2017-00140 on february 23, 2017.March 17, 2017 additional information: siemens healthcare diagnostics' investigation has determined that the discordant result displayed a rtc-fs flag on the advia 2120i with dual aspirate autosampler (daa).This was due to a problem with the gaussian fit of the reticulocyte absorption histogram.The optipoint printout provided by the customer also showed the pulse width (modulator) was too high and should be 21.0 +/- 0.3.The other advia 2120i with dual aspirate autosampler (daa) did not report a flag and that result was accepted and a corrected report was issued to the physician.Siemens investigation determined that the cause of the discordant high %reticulocyte result was due to failure of the customer to follow the operator guide instructions.The operator's guide states for the operator to perform a reticulocyte count using a manual smear when an rtc-fs flag is generated.Whenever such flags are triggered, the user should review the results and take the action recommended.The customer released a flagged %reticulocyte result without following their laboratory's procedure on how to handle such results.The instrument is performing within specifications.No further evaluation of this device is required.Method code, result code and conclusion code were updated to reflect the results of the investigation.
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