Medical device manufacturer, Roche, has issued a medical device safety alert concerning its cobas e 801 module/analytical units and ProCell II M. The affected products are identified as follow:
The manufacturer has received complaints describing signal drops on some affected product, due to degrading of ProCell II M in the flowpath caused by bacterial contamination. Investigations have shown that when this issue occurs, it may cause discrepant results approximately 15 determinations after the ProCell II M bottle changeover, for a period of up to 20 consecutive measurements.
ProCell II M is a system solution used on cobas e 801 for the transport of the assay reactant mixture to the measuring cell and for Electrochemiluminescence (ECL) signal generation. There are two bottles of ProCell II M present on the affected product: an active bottle that is used for measurements and a stand-by bottle that is automatically used right after the first bottle is empty (ProCell II M bottle changeover).
According to the manufacturer, the potentially affected products are only those that show at least two of the following conditions:
On affected products, the ProCell II M flowpath is covered by a biofilm with ProCell II M resistant bacteria. If ProCell II M inside the flowpath is not exchanged regularly, like for example in the stand-by ProCell II M bottle flowpath, bacteria can degrade the components of ProCell II M resulting in a reduced ECL signal generating capacity. The impact of this degradation is described for sandwich and competitive assays, as stated in the advisory.
ProCell M (used on cobas e 601 module, cobas e 602 module and MODULAR ANALYTICS E-170) and ProCell (used on cobas e 411 analyzer) are not affected.
The manufacturer will schedule a visit to switch affected products to the updated ProCell II M. Until the updated ProCell II M is available at customer sites, a decontamination of the ProCell II M flowpath every 4 weeks should be performed by the manufacturer's representative for the affected products that show at least two of the conditions mentioned above. In order to improve the efficiency of the ProCell II M flowpath decontamination procedure, the related service procedure has been revised and proven to mitigate the risk of contamination.
The affected users are advised to take the actions stated in the Field Safety Notice [SBN-CPS-2008-025].
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 22 March 2019