Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity hq Analyzer [List Number: 09P68-01].
The manufacturer has identified that a patient sample result with an "MCHC Out of Range. Check Sample Integrity" flag on the Alinity hq analyzer may indicate that the processed sample contained a clot.
According to the manufacturer, if the analyzer is not halted by the user, the system will continue to process samples. Subsequent results may be impacted and may not be flagged. Patient Complete Blood Count (CBC) results that are generated following the aspiration of a clot may be incorrect (falsely decreased).
The manufacturer is continuing to investigate this issue and future system upgrades are in development. In the meantime, the affected users are advised to take the following actions:
- When the "MCHC Out of Range. Check Sample Integrity" flag is triggered, this message may indicate a short sample or a clotted sample. Pause the system when the notification is detected. Check the sample that triggered the flag for the presence of clots. If no clot is found, resume operation of the analyzer and no further actions are needed;
- If a clot is found, perform the daily (5001) AutoClean maintenance procedure and run background and Quality Controls. Samples processed after the "MCHC Out of Range. Check Sample Integrity" data invalidating flag and before the Quality Control values are confirmed should be re-tested, even if no flags, invalid results, delta checks or results outside of the reference range were generated;
- Review the FSN with Medical Director and follow the laboratory protocol regarding the need for reviewing previously reported patient results;
- Clots in specimens are a condition that may affect CBC results. Although the Alinity hq has been designed to flag such samples, it may not always be possible to do so. To minimize the risk of clot formation, follow the instructions in the Alinity h-series Operations Manual, "Requirements for handling the specimens." Collect all whole blood specimens according to laboratory procedures. Follow the recommendations of the collection tube manufacturer. Comply with all precautions for blood collection by venipuncture to prevent clotting or specimen hemolysis;
- No changes are required to the recommended maintenance schedule.
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 14 February 2019