Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its following devices:

• UniCel DxH 800 Coulter Cellular Analysis System [Reference: 629029, B24465, B24802, B68304, B66445, B63322; Software Version: 3.2.0 and below];
• UniCel DxH 600 Coulter Cellular Analysis System [Reference: B23858; Software Version: 1.3.0 and below].

The manufacturer has confirmed complaints of sporadic erroneously elevated platelet results without flags or system messages. Other parameters are not affected by the issue.

Patient results may be affected. No injury has been reported in association with the issue.

During patient's follow-up, the affected users are advised to consider unexpected elevated platelet levels as possible erroneous results due to the failure and ensure implementation of the following actions:

• Use all available features to assess patient results, including reference ranges, action and critical limits, instrument system flags, codes, messages, delta checks, XM, and decision rules;
• Follow their laboratory's standard operating procedure for confirming unexpected results;
• Communicate to their medical director the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features;
• Consult with the medical director to determine if a retrospective review of results is warranted.

According to the manufacturer, DxH 800 version 3.2.1 and DxH 600 version 1.3.1 are not affected by the issue. The manufacturer will be prioritizing the upgrades for the systems.

Alternatively, the manufacturer is working on the development of a self-installable software patch option, in lieu of the software upgrade, to expedite resolution and minimize impact on laboratory workflow.

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 10 August 2018