Urgent Field Safety Notice
Contents
1. AXIS SHIELD Innovation for Life Urgent Field Safety Notice Afinion CRP system Affected products Afinion AS100 Analyzer REF 1115027 1115173 1115174 1115176 1115172 1115175 1115507 1115419 1115516 Afinion CRP REF 1115013 1115014 1115377 Afinion CRP Control REF 1114993 June 2012 Attention Customers within EU EEA Turkey and Switzerland FSCA identifier MP12 1086 Warning about possible misinterpretation of an information code as a CRP test result and reduced opened vial stability of Afinion CRP Control 1 POTENTIAL MISINTERPRETATION OF INFORMATION CODE 1 1 Description of the problem Axis Shield PoC AS the manufacturer of the Afinion CRP system warns that an information code error code which is displayed on the Analyzer screen might potentially be misinterpreted as a high CRP result There have been four 4 such reportable incidents since the launch of Afinion CRP in 2005 which might have resulted in suboptimal follow up and treatment of the affected patients The analysis of an Afinion test cartridge is supervised by the Afinion AS100 Analyzer error detection system In case of a sample or device related error or limitation an information code is displayed by a 3 digit number 100 200 or 300 series along with an alert icon The possible cause of the information code and the action to take is explained in the Afinion AS100 User manual 1 2 Corrective actions by the manufac2. 2 REDUCED OPENED VIAL STABILITY OF AFINION CRP CONTROL 2 1 Description of the problem Axis Shield PoC AS the manufacturer of the Afinion system warns that the stability of opened vials of Afinion CRP Control has been reduced from 8 to 4 weeks The CRP concentration in frequently opened control vials may increase due to evaporation 2 2 Corrective actions by the manufacturer Based on recent in use stability testing of opened vials Axis Shield PoC AS has concluded that the use of an opened vial of Afinion CRP Control C I or C II should be limited to 4 FSCA identifier MP12 1086 2012 06 Page 2 of 3 Ss AXIS SHIELD Ne SQ FY innovation for Life weeks The Afinion CRP Control Package Insert has been revised The new revision number is 1115826 2011 10 packed with lot no 10156405 and onwards 2 3 Corrective actions by the user of the Afinion CRP system 1 Please be aware of the recommended limitation of 4 weeks stability of the opened vials of Afinion CRP Control C I or C II 2 Follow the Afinion CRP Control recommendations in the Package Insert for handling the controls See extracts from the Package Insert below Opened control vials e Opened control vials are stable for 4 weeks when stored refrigerated 2 8 C It is recommended to note the date of opening on the vial label e Always store the control vials refrigerated 2 8 C in an upright position when not in use e The controls can be
3. used directly from the refrigerator without equilibration to room temperature Verifying the control results The measured values should be within the acceptable range stated for the Afinion CRP Control C I and Control C II If the result obtained is outside the acceptable limits make sure that e patient samples are not analysed until control results are within acceptable range e the control vial has not passed the expiry date the control vial has not been used for more than 4 weeks the control vial and the CRP test kit have been stored according to recommendations there is no evidence of bacterial or fungal contamination of the control vial Correct any procedural error and re test the control material If no procedural errors are detected Re test the control material using a new control vial Examine the laboratory s quality control record to investigate the frequency of control failures Ensure that there is no trend in out of range quality control results Patient results must be declared invalid when controls do not perform as expected Contact your local supplier for advice before analysing patient samples Transmission of this Field Safety Notice This notice needs to be passed on to all those who need to be aware within your Organization or to any organization where the potentially affected devices have been transferred Axis Shield PoC AS confirms that this notice has been notified the appropriate Regulatory Agency
4. in affected member states in EU EEA Turkey and Switzerland Axis Shield PoC AS an Alere company P O Box 6863 Rodel kka NO 0504 Oslo Norway www axis shield com FSCA identifier MP12 1086 2012 06 Page 3 of 3
5. turer To significantly reduce the risk of misinterpreting an information code as an assay result a change in the information code view has been implemented valid from SW 4 02 The message Information code appears in the selected language along with a hash sign and the code number FSCA identifier MP12 1086 2012 06 Page 1 of 3 AXIS SHIELD CS 4 A Innovation for Life QSSv Please see the illustration below of the information code view valid for SW lt 4 01 and of the improved information code view valid for SW 4 02 In contrast a CRP result gt 200 mg L is illustrated A CRP 212 Information code gt 200 mg L 212 oY OY OY J a Information code view b Information code view c CRP test result view valid for SW lt 4 01 valid for SW 4 02 CRP gt 200 mg L 1 3 Corrective actions by the user of the Afinion CRP system 1 Please read the instructions in the Afinion AS100 Analyzer User Manual and in the Afinion CRP Package Insert to revise how to correctly interpret an information code versus a CRP result 2 The more intuitive information code view implemented from SW 4 02 will significantly decrease the likelihood of misinterpretation The Afinion Analyzer SW 4 02 is launched by the manufacturer and the upgrading of the instruments is in progress You will be contacted by your supplier if you have not already been contacted regarding upgrading of your Afinion AS100 Analyzer
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