CoaguChek PT Test Strips - Potential for Erroneous Patient Results Due to Manufacturing Issue
Test strips used on CoaguChek and CoaguChek S meters only
Dear Customer,
Roche Diagnostics is notifying all CoaguChek / CoaguChek S users of a product issue affecting all CoaguChek PT test strips used on CoaguChek and CoaguChek S only.
Issue:
Roche Diagnostics have confirmed the potential for a test strip defect that may cause falsely elevated INR results and we are taking corrective action with highest priority. To date there has only been one confirmed incident in the USA and an internal investigation indicates the likelihood of only a few errors per 1 million tests.
It is important to state that the CoaguChek XS PT test strips used in the XS and XS Plus meters are not affected by this issue
Root Cause:
A falsely high INR test result can occur due to a production problem during the manufacture of the test strip. We
have established a cause for this issue and we are working swiftly to correct the situation.
Clinical Significance:
CoaguChek PT test strips are used by CoaguChek customers to determine INR results of patients taking anticoagulants, such as warfarin. Anti-coagulants are used to treat patients with a potential for blood clots, for example, patients with heart valve replacements, certain types of heart disease or blood clots in their legs.
If one of the test strips is affected by this problem it can result in either a "test error message" displayed on the meter or a falsely high INR result. The consequence of a falsely high INR result is that an incorrect dose of anticoagulant may be administered.
Action Required:
When an INR result of 4.0 or greater is obtained with a CoaguChek or CoaguChek S, it is recommended for this test to be repeated. The repeat test should be performed using strips from a different lot number (see enclosed visuals). In addition a fresh sample from a different finger should be used. If the second result has a difference of more than 0.5 INR unit from the first result, it is recommended to contact your health care professional.
Good clinical practice advises repeat testing for any unexpected results and regular testing (weekly or two-weekly) to optimise good anticoagulant control.
These repeat tests for INR's greater than 4.0 should be performed whenever you are running a test with your CoaguChek or CoaguChek S meter until further notice. Roche Diagnostics fully expect this issue to be resolved by early 2007.
Please find enclosed pictures on how to identify the lot number and roll number, respectively on the test strip box and on the test strip pouch. In case you do not have strips from two different lots or rolls please contact Roche Diagnostics for another CoaguChek PT test strip box which will be delivered free of charge.
Additional Information:
Letters are being sent to patients and all appropriate health care professionals in primary and secondary care regarding this voluntary action.
If you are particularly concerned over performing repeat tests after reading this letter, Roche Diagnostics suggest that you speak with your health care professional and discuss alternative methods for measuring your INR results over the coming weeks until this situation is rectified.
Roche Diagnostics is using all available means to resolve this issue with our test strips in the shortest time possible. We will write to advise when repeat testing is no longer necessary. In the interim, the extra test strips required for repeat testing will be provided free of charge by Roche Diagnostics by calling our CoaguChek Careline free on 0808 100 7666.
Patient safety is our paramount concern. Roche Diagnostics apologise for both the concern and inconvenience this will cause you and thank you in advance for your understanding.
Yours sincerely,
