Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its REMISOL Advance versions 1.6 to 1.9.

The manufacturer is initiating a field action for the product listed above. REMISOL Advance archives test results and patient information on a database, which allows the use of this data for later manual review. The manufacturer identified a case where in a customer's database there were duplicated archived results that did not match the Patient ID due to a deadlock in the database.

Due to the technical structure of the database the current and last archived results (Previous results) are not affected. The wrong archived results are not used for delta checking or autovalidation, and hence this anomaly will not result in an erroneous result being reported to the LIS. This issue can potentially happen at each Remisol Advance archive without any warning (on REMISOL Advance versions 1.6, 1.7, 1.8 & 1.9). The erroneous archived results could be used for manual review, when requested in the "Archives ➔ Previous Results Search" window. Erroneous archived results will never be displayed in the Remisol current request window.

The issue will be addressed by applying a software tool capable of:

• Determining whether the system is affected (i.e. whether incorrectly archived results exist)
• If any erroneous archived result is found, the tool will:
• Export the list of erroneous archived results and the corresponding date, Patient ID and Sample ID
• Remove the erroneous archived results
• Correcting a setting in the SQL database to prevent the issue from happening in the future

Until the software tool is applied, affected users should take the following actions:-

• Affected users should be aware of the problem when performing manual review via the "Archived request window".
• If there is the need to review and make decisions based on archived results that are older than the previous result, affected users should confirm that the result is correct by checking the results stored in the Laboratory Information System (LIS) and/or the Electronic Medical Records (EMR).
• When the tool described in the "Resolution" section below is applied, affected users will receive a list of affected results (if any), which will allow affected users to consider if any additional action needs to be taken based on the trend in patient data over time and how their laboratory uses that information.

The manufacturer will arrange a date and time for the tool to be applied.

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 4 October 2019