Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its AutoMate 2500 Family systems with Sorting-Drive software upgraded from version 4.1.2 to 4.2.

The manufacturer has identified a software error with Sorting-Drive version 4.2. This issue only impacts customers that have upgraded from Sorting-Drive software version 4.1.2 to version 4.2. The software error prevents the ability of the Sorting-Drive to process updates to original test orders received via the Laboratory Information System (LIS). Updates to original test orders consist of the following three (3) actions:

• An already completed test is rerun/repeated
• An additional test is added to an existing test order
• A test is removed or deleted from an existing test order

Any test updates to an original order will not be processed. The Sorting-Drive software provides no notification that the test updates were not processed. This may cause a delay in results for any tests which are requested after the original test order (i.e. reruns or added tests).

Any updates to original test orders (reruns or added tests) need to be processed manually, as described below:

• Monitor the LIS to identify test orders which have not been processed in the normal timeframe.
• Identify which of these were requested after the original test order (i.e., reruns or added tests).
• Locate the associated samples and load these directly onto the analyzer for processing, bypassing the AutoMate system.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 31 May 2016