Urgent Field Safety Notice – Update2
Contents
1. Urgent Field Safety Notice Update2 Notice Ref No B APD_2013_06 Document Date 08 May 2013 Type of Action Field Corrective Action PRODUCT AFFECTED CoaguChek XS SYSTEM AFFECTED See above 04625412xxx MATERIAL NUMBERS SERIAL NO IF All serial numbers for CoaguChek XS APPLICABLE SUNNAR T OES ERROR 6 might require an urgent alternative INR l measurement due to possibly high INR values ROTONREGOIRED Under certain circumstances with ERROR 6 l patients must contact their physician immediately Technical Services CONTACTS Country Reason for notice User information for your CoaguChek XS instrument FSN_SB_RPD_Update2_CoaguChek XS 1 3 Action required Dear Sir or Madam You have been using our CoaguChek XS instrument for some time to regularly monitor your coagulation rate As you know the CoaguChek XS instrument measures your coagulation status up to an INR value of 8 0 It is Known that in very rare situations INR values greater than 8 0 can occur for example if the patient is undergoing antibiotic treatment or chemotherapy The CoaguChek XS instrument detects these very high values and displays the following two messages for your protection or Fig 2 In both cases the user manual advises you to consult your doctor immediately In April 2013 we were made aware of a case in Norway in which antibiotic treatment resulted in a patient having an INR value greater than 10 However t2. e the CoaguChek XS instrument was introduced in 2006 the Norwegian case is the only case anywhere in the world in which an INR value greater than 10 has produced an error 6 Our staff at the CoaguChek Customer Service Center will be happy to answer any questions you may have regarding this letter You can call the CoaguChek Customer Service Center on date time on Telephone number FSN_SB_RPD_Update2_CoaguChek XS 3 3
3. he CoaguChek XS instrument returned the following display Fig 3 The user manual tells you that an error has occurred in the measurement process Although a very high INR value is practically excluded as a reason for this error message we have decided as a precautionary measure to inform our CoaguChek XS customers about the correct procedure to follow if an error 6 message is displayed Fig 3 What do I have to do if my CoaguChek XS instrument displays error 6 lf this happens the most likely cause is that an error has occurred in the measurement process Please turn off the CoaguChek XS instrument remove the test strip and repeat the measurement with a new test strip Make sure that you do not squeeze your finger while taking the blood and that you do not touch the test strip during the measurement these are the two most frequent causes of an error 6 If you follow the correct procedure and error 6 is displayed again you should immediately consult your FSN_SB_RPD_Update2_CoaguChek XS 2 3 doctor to have your coagulation status checked This is particularly important for you The CoaguChek XS instrument continues to perfectly measure your INR values even if you are receiving antibiotic treatment or chemotherapy The CoaguChek XS instrument never produces incorrect values 99 99 of cases in which an error 6 is displayed result from an incorrect measurement process Sinc
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