Medical device manufacturer, Abbott GmbH, has issued a medical device safety alert concerning its Alinity ci‐series System Control Module (SCM) [List Number: 03R70-01; All Serial Number].
The manufacturer has identified 3 issues related to Levey‐Jennings data in Alinity ci‐series Software version 3.1.0.
Issue 1: Levey‐Jennings Display
- 3.1.0 software implemented a new sorting method using a date/time algorithm. However, an issue was identified where the operating system could not interpret that format. The software turned the date and time into an alpha numeric string. Because the system now sorts by an alpha numeric string, the order of data points displayed on the Levey‐Jennings graph may not display in chronological order depending on the Date and Time format configured in the software.
- If using the Alinity ci‐series user interface to view Levey‐Jennings graphs, affected users should change software configuration to Date Format: YYYY/MM/DD Time Format: 24 Hour Clock.
Issue 2: Printed Levey‐ Jennings Graph Missing Data Points
- An issue was identified when the customer uses the Quality Control (QC) Selection to print Levey‐Jennings graphs from a multi‐module system. This may result in the report omitting data for one or more of the processing modules. This issue only impacts workstations with two or more of the same processing module. Stand‐alone Alinity c or Alinity i modules and the Alinity ci workstations are not impacted.
- There are 2 possible options to avoid this issue:
- Use QC Summary screen rather than the new QC Selection flyout to construct the graphs to be printed.
- When using the QC Selection flyout to construct the graphs to be printed, only select a single processing module.
Issue 3: QC Selection flyout does not display the Selection Box for all Available Levels
- An issue was identified where the user is not presented with all levels of QC on the QC selection flyout. For example, an Alinity system may have 3 levels of QC configured, but on the QC selection flyout the operator is only presented with the option to select one or two of the levels. The cause is an incorrect attribute being used within the software to identify the levels available for selection. If a QC level is not completely configured by the user for all assays, the QC selection flyout may not display the level as an available option even though there may be QC data for that QC level. Affected users should use the QC Summary screen to display all available QC levels rather than the new QC Selection flyout.
The issues identified do not create the potential for incorrect results as all control flagging and Westgard rule functions are present. The issues identified do not impact test processing.
Affected users should follow the necessary actions required until updated software is available.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 March 2020