Important Safety Alert
BacT/ALERT® BacT/VIEW® Users
To: Blood Bank and Laboratory Services Supervisors
FDA is informing the healthcare community of a database corruption situation that may lead to a failure to report positive cultures or cause a delay in appropriate patient therapy when using the BacT/VIEW® data management feature of Biomerieux’s BacT/ALERT® system. Database corruptions can interrupt communication between the BacT/VIEW® computer and a site’s laboratory information management system/laboratory information system (LIMS/LIS). While this type of corruption will not impact the accuracy of your bottle results, it can cause a delay in the transmission of these results to your site’s LIMS/LIS system. Awareness and understanding of this issue is important for laboratories who:
- Provide patient testing and blood component bacterial testing services to blood banks and/or hospital blood transfusion services and,
- Rely solely upon their LIMS/LIS system for notification of positive bottle results.
It is important that the information below be communicated appropriately within your laboratory to increase awareness of:
- What happens when a PC database corruption occurs,
- Where to find instructions within the User’s Manual that will allow you to troubleshoot the issue,
- Actions that may be taken in order to reduce the likelihood that a PC database corruption will occur, and
- Actions that may be taken in order to reduce the impact of a database corruption on your laboratory’s ability to get current results from your LIMS/LIS system.
Additional information to help you address this issue can be obtained at http://industry.biomerieux-usa.com/news/pressreleases/bactview_fdaupdate.htm.