I just learned that Roche issued what they call an 'Urgent Medical Device Correction'. I've heard this referred to as a 'recall' -- but it isnt, there's no apparent fix, and the only 'modification' that Roche will apparently make is new instructions in boxes of strips.
Quoting from the 'Correction,' dated 5/16/13, it starts out saying that 'Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an "ERROR 6" message is displayed.'
The document warns that 'If the "ERROR 6" message is displayed repeatedly, use an alternative method to determine an INR result. Patient self-testers are being asked to contact their physician without delay if "ERROR 6" is displayed repeatedly on their meter."
For most of us, this is probably a non-issue, but for patients on chemotherapy or who are taking antibiotics, the "ERROR 6" issue may be a problem. Roche reported that 'only one case of high INR values related to the "ERROR 6" issue has been reported using the CoaguChek XS Meter." This may not be that big a deal, although getting the error message rather than a result can be a problem. Plus, it's important for those on warfarin to be aware that if they get the "ERROR 6" message, they should seek medical assistance.
Quoting from the 'Correction,' dated 5/16/13, it starts out saying that 'Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an "ERROR 6" message is displayed.'
The document warns that 'If the "ERROR 6" message is displayed repeatedly, use an alternative method to determine an INR result. Patient self-testers are being asked to contact their physician without delay if "ERROR 6" is displayed repeatedly on their meter."
For most of us, this is probably a non-issue, but for patients on chemotherapy or who are taking antibiotics, the "ERROR 6" issue may be a problem. Roche reported that 'only one case of high INR values related to the "ERROR 6" issue has been reported using the CoaguChek XS Meter." This may not be that big a deal, although getting the error message rather than a result can be a problem. Plus, it's important for those on warfarin to be aware that if they get the "ERROR 6" message, they should seek medical assistance.