Important Safety Alerts

Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its cobas e 411 analyzer. The details of the affected products are as follows:

• Product names: 1) cobas e 411 analyzer (disk system); 2) cobas e 411 analyzer (rack system)
• Catalogue numbers: 1) 04775279001; 2) 04775201001
• All software versions

The manufacturer informs customers that in very rare cases a software (SW) malfunction in the Sample&Control datafile can occur which may lead to a potential data mismatch. This SW malfunction only occurs:

• when the "Sample Data Clear" function is not performed daily as indicated in the Operator's Manual, and
• when the Sample&Control datafile of the cobas e 411 analyzer is filled with > 2000 records.

According to the manufacturer , all tests that are run on cobas e 411 are potentially affected whereas the impact of the data mismatch cannot be predicted. The manufacturer has received a total of four customer complaints for this issue.

The manufacturer advises customers to perform the following actions:

• Perform a "Sample Data Clear" daily until the new SW has been installed. As Sample Data Clear deletes all sample records and moves QC data to the QC view. It is recommended to perform the backup procedure on a regular basis, depending on data volume and the regulations at customer site. If the system is connected to a host, make sure that all data has been uploaded before performing a sample data clear.
• When the new SW version is available it will be installed as a mandatory update to the system.

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 29 June 2017