Siemens healthcare diagnostics has identified five feature issues with the syngo lab data manager.The issues pertain to result unit conversions, quality control processing, virus protection, system performance degradation, and orders received from lis being rejected.An urgent medical device correction (umdc) entitled "syngo lab data manager system software issues" was sent to customers in the united states in august 2015.An urgent field safety notice (ufsn) entitled "syngo lab data manager system software issues" was sent to customers outside of the united states in august 2015.The umdc and ufsn describe the issues and provide actions the customer can take to prevent and mitigate the issues.
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When the customer is reviewing quality control (qc) results on their syngo lab data manager, if a qc result has either failed a rule or has an instrument error, the result remains in unresolved qc alerts after the customer has addressed the issue by excluding the result.The error will sometimes have a different description from the error originally presented to the customer.There are no known reports of adverse health consequences due to this issue.
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