Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity hq Analyzer [List Number: 09P68-01; Serial Numbers: All].
The manufacturer has identified two issues related to Alinity h-series Analyzer Software Version 4.1 and below:
- When the paediatric sample tube BD Microtainer MAP Dipotassium EDTA 1.0mg is run in the Closed Mode, the Alinity-h software v 4.0 and above generates Message code 3727 "Tube bottom not detected", which indicates that the sample probe did not reach the tube bottom and sample was not aspirated. However, sample is aspirated and results are invalidated by the system.
- The Embedded Analyzer Engine (EAE) logs on the Alinity hq instrument indicates the occurrence of a slow memory leak. Once the instrument has processed approximately 5000 samples, the system will start to display zeros (0.00) on the Results Screen along with algorithm failure data invalidating flags displayed on the Extended tab of the Results Details screen on System Control Center (SCC) for certain samples.
According to the manufacturer, there are no hazards or impact to patient results due to these issues.
The affected users are required to take the following actions:
- Ensure sample tubes meet the size criteria as defined in the Alinity h-series Operator's Manual Section 4 Performance characteristics and specifications.
- BD Microtainer MAP Dipotassium EDTA 1.0 mg tubes can only be used in Open Mode. The issue will be resolved in Software Version 4.2, which is expected to be released in February 2020. Once the update has been installed on their system, they will be able to use the BD Microtainer MAP Dipotassium EDTA 1.0 mg tubes in Closed and Open Mode.
- To prevent the memory leak of the EAE, cycle power to the instrument once a week or when the issue occurs (Alinity h-series Operations Manual, 80000023-107, 2019-09-03, Section 5 Operating Instructions, System cycle power, start, pause, and stop). The issue will also be resolved in Software Version 4.2. Once the update has been installed on their system, the issue will no longer occur.
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 December 2019