Medical device manufacturer, Roche, has issued a medical device safety alert concerning its cobas infinity core license. The affected device is identified as follow:-
Subsequent to an alarm starting with a "<" symbol the alarm flag IDs are not displayed in the validation screen. Alarms are not displayed on the Validation screen if:
According to the manufacturer, affected users using the alarm mapping function to create system flags that start with "<" are also affected. Any alarm mapping defined to map an instrument alarm to a system alarm that starts with a "<" symbol will lead to a situation that system flags are not visible for manual validation. The following Roche instruments are not sending instrument alarms which starts with "<":
The manufacturer has initiated a Corrective Action and Preventive Actions (CAPA) to address this issue. The issue will be fixed in cobas infinity version 2.5.5 (to correct affected version 2.xx) and 3.01.05 (to correct affected version 3.xx) and will be released by the end of 2019.
The issue is limited to the visualization of the alarms in the Validation screen. All the alarms are correctly received and stored in the database. Therefore, the potentially missing alarms can cause wrong validation only during the manual validation process.
If validation is done automatically from cobas infinity, then the validation is done correctly and according the defined validation criteria. If the results are sent to the Laboratory Information System (LIS), then the alarm flags are properly sent without a problem.
Affected users have to update to cobas infinity version 2.5.5 or version 3.01.05.
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 24 December 2019