The U.S. Food and Drug Administration (FDA) and the Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning INRatio2 PT/INR Professional Test Strips, manufactured by Alere.
There were complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. The manufacturer has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. The Alere INRatio2 PT/INR Professional Test Strip results were between 3.1 – 12.2 INR units lower than the laboratory result. There may be risk of inaccurately low INR result.
The manufacturer has advised users to immediately stop using the Alere INRatio2 PT/INR Professional Test Strips. It has also advised users to use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer. The manufacturer is notifying healthcare providers of an update to the limitations of use for the INRatio 2 PT/INR tests strips. Consumers are being provided with a Safety Alert notification advising of potential issues with the accuracy of the device and the correct clinical practice with regard to medication dosing. Furthermore, the manufacturer will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139).
Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). For details, please refer to:
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 7 May 2014