Important Safety Alerts

Medical device manufacturer, TECHNIDATA S.A.S, has initiated a medical device field safety corrective action concerning TD-Synergy with software version 11.31.C.

According to the manufacturer, a software defect has been identified. In certain conditions, results which have not been clinically validated are printed on the cumulative result printouts.

The defect only applies to sites using cumulative result reports by department. If the following sequence of events takes place, results which have not been clinically validated, can be printed on the cumulative result printouts.

• If a request R1 is created for a patient P1 and if this request includes a test T1 where a result has to be validated;
• If a new request R2 is created for the same patient P1 and if the results of R2 request tests do not need to be clinically validated or are clinically validated before R1 request tests;
• Then the printout of the cumulative report for request R2 results is triggered, including R1 request results with a T1 test which has not been clinically validated.

According to the manufacturer, the affected device was distributed in Hong Kong and the software correction has already been implemented.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 19 October 2012