Health Canada — Medical Devices · Canada · 2018-04-03 · Type II
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Reported risk: Software anomaly (reference dr35041) with TD-Synergy version v11.31 or later. This anomaly results in consequences for users only when the TD-Synergy system is connected to another system and uses one of these two communication methods. Transmission of results in HL7 format from TD-Synergy to a host system including results of date type. Sharing of TD-Synergy data with a reference laboratory including complementary parameters of date type. This anomaly affects only results of date type or complementary parameters of date type. Nature of the defect (real or potential): Depending on the date format used, the system may invert the date's day and month. For example, the system can transmit a date as “February 3, 2015” instead of “March 2, 2015” The system transmits results of date type or review requests with complementary parameters of date type in HL7 format. The communication module's service window uses a local account system that has a regional parameter corresponding to common wording that uses a date format in which the day precedes the month (e.g., “day/month/year” format such as “dd/mm/yy” or “d/m/yy”). Or The communication module's service window uses a specific user account, and this user uses a date format in which the day precedes the month (e.g., “day/month/year” format such as “dd/mm/yy” or “d/m/yy”). The defect does not occur if the date format used is “month/day/year” (mm/dd/yyyy).
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