Urgent Field Safety Notice

Transcription

1 Urgent Field Safety Notice Notice Ref No: PAN_SB_RPD_ Document Date: PRODUCT AFFECTED: PRODUCT DESCRIPTION: SYSTEM AFFECTED: Reference Electrode OMNI Micro-Electrode/Reference Electrode <OMNI S and cobas b 221 systems> MATERIAL NUMBER: LOT NO (IF APPLICABLE): SUMMARY OF ISSUE: ACTION REQUIRED: CONTACTS: All lots Membrane within the electrode housing may start to leak, potentially, leading to erroneous ph and sodium results. Change the affected electrode, if it has been installed for over 52 weeks. Technical Services: Country: 1/10

2 Dear valued cobas b 221 system customer, We regret to inform you about an issue with reference electrodes for the OMNI S and cobas b 221 systems. Description of the Situation Reference electrodes have been used far beyond the in-use lifetime guaranteed, by the manufacturer. In this situation, a membrane within the electrode housing can start to shrink. This may eventually cause unsealed areas where the 1.2 mol/l KCl solution, used within the electrode, may slowly seep out of the electrode. If this occurs, it can seep to the nearby grounding contact, whereby, a parallel electrode to the reference electrode is formed. Thus the performance of the reference electrode is influenced, by this issue. In addition, this may cause a ph-offset, which could also happen with sodium (Na). Other ion parameters are not affected. Investigation Result The guaranteed in-use life time is 52 weeks. Previously, customers had not been sufficiently informed regarding this limitation. Therefore, aging of the glue may occur and cause a leakage. Risk Assessment The bias of results is unpredictable. However, a maximum bias of 0.16 for ph was observed during investigation. Frequency of Occurrence The frequency of occurrence is moderate: 4 cases were received, within No cases had been reported before Detectability The issue cannot be detected by a failed QC. However, when the user opens the measuring chamber, the issue can easily be detected, with a salt bridge of the electrode clearly visible on the reference electrode. 2/10

3 Counter-measures A revision of the software is planned to be introduced in the second half of 2014, indicating a maintenance reminder for the reference electrode change. Until the new software, as well as the updated instructions for use, is available you are requested to follow the following workaround: Workaround for Roche OMNI S and cobas b 221 systems regarding the reference electrode replacement: How to setup replace reference electrode in a yearly maintenance cycle Go to Setup/Times&intervals and choose Maintenance schedule. 3/10

4 Press the button New to setup the maintenance task for replacing the reference electrode in a yearly cycle. Enter all fields by using the keyboard symbol and then press the arrow back symbol to safe the setup Important: Enter the interval you install the reference electrode, choose 1 year since the reference electrode does have an in-use time of 52 weeks. 4/10

5 This described setup has to be done also for the Reference electrode for ISE and MSS (UREA). Press the arrow back to safe the setup and go back to the analyzer mode. How to perform the replacement of the reference electrode As soon the Perform maintenance appears (as defined in a yearly cycle) on the top right corner, the replacement of the reference electrode can be done. 5/10

6 First check under System/Utilities/Maintenance or System/Quick Access/Maintenance the yellow highlighted maintenance task, which has to be done. In this case, the replacement of the BG reference electrode is requested. Open the Measuring chamber and perform the replacement of the reference electrode as described in the Instructions for Use. After the scan of the barcode the details are shown under Sensor data. 6/10

7 After the replacement of the reference electrode has been done, go to System/Utilities/Maintenance or System/Quick Access/Maintenance to confirm the action. Press Done for the yellow highlighted maintenance task. The white message on the top Perform maintenance will disappear and change to a green Status OK. Important: After the replacement of the reference electrode has been confirmed by pressing Done, the reminder will appear after 1 year again. How to check the replacement of the reference electrode Under Databases/Instrument, the replacement of the reference electrode can be checked in detail. 7/10

8 Scroll on the side till Reference is visible, then select and use the symbol about the reference electrode replacement., to see all details Details about the replacement of the reference electrode as date and time of installation and the lot-number are visible in here. 8/10

9 With Software SW 8.1 and newer, there will also information about the reference electrode under Info/Versions With Software SW 8.1 and newer, the reference electrode will also be listed as the other electrodes with the installation date. 9/10

10 Actions required: Check the installation date of reference electrodes on all of your OMNI S and cobas b 221 systems If the reference electrode has been installed on the analyzer for more than 52 weeks, then change immediately. We sincerely apologize for any inconvenience caused by this issue. Yours faithfully, Roche Diagnostics GmbH <Signature(s) according to guidelines> The undersign confirms that this notice has been notified to the appropriate Regulatory Agency (Closing paragraph) Signature 10/10