Siemens healthcare diagnostics has identified five feature issues with the (b)(4).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 "(b)(4)" was sent to customers in the united states in august 2015.An urgent field safety notice (ufsn) entitled "(b)(4)" 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.
|
When a new quality control (qc) result contains an error code on the (b)(4), the user can exclude the result and proceed with running qc.However, if a second result with an error code occurs and the user tries to exclude the result, the error from the first qc result replaces the second error.The user must then manually exclude the error result a second time.If the auto verification feature is being used, all results will be held.There are no known reports of adverse health consequences due to this issue.
|