Urgent Field Safety Notice

Transcription

1 Urgent Field Safety Notice Notice Ref No: PAN_SB_RPD_ Document Date: PRODUCT AFFECTED: PRODUCT DESCRIPTION: Reference Electrode OMNI Micro-Electrode/Reference Electrode SYSTEM AFFECTED: <OMNI C, cobas b 121 and b 121<BGE> 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: Dear valued cobas b 121 system customer, We regret to inform you about an issue with reference electrodes for the Roche OMNI c, cobas b 121 and cobas b 121<BGE> systems. 1/7

2 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 2013 (on cobas b 221 system) 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. Counter-measures 2/7

3 A revision to the existing Instructions for Use will be distributed explaining the need to replace the reference electrode, after the guaranteed in-use life time of 52 weeks. In addition, it will explain how customers can find out the actual status of the reference electrode in-use and that they must activate a manual maintenance scheduler function. Until the updated instructions for use are available you are requested to follow the following workaround: Workaround for Roche OMNI C, cobas b 121 and cobas b 121<BGE> systems: Chapter 1: How to check the Reference Electrode installation date? From Ready screen, press Info button, then select Sensor status and select Ref in the left column, in order to see the lot number and exchange date (installation date) of the Reference Electrode. See the example below: Figure 1 Figure 2 Figure 3 NOTE: If the electrode was exchanged more than one year ago, then the Reference Electrode has to be replaced immediately! 3/7

4 Chapter 2: How to setup the Maintenance Scheduler in order to receive a reminder that the Reference Electrode has to be replaced (after one year)? According to the installation date (electrode exchange date) for the Reference Electrode, as seen above in the chapter 1, the Maintenance reminder can be activated in order to avoid forgetting after one year that the Reference Electrode has to be replaced again. From Ready screen, press Setup button, select Times and Intervals and select Maintenance scheduler. Scroll down until the Add button is active, press Add button, press the Keyboard button and enter the maintenance name (REPLACE REF. ELECT.). Press Details, select the parameter, press the Keyboard button and enter the following information: a. Cycle (Yearly) b. Time (when the reminder has to be displayed) c. Date (date when the Reference Electrode was replaced, see chapter 1) d. Sample counter (No) e. Reminder (On) f. Archive (On). See the example below: Figure 4 Figure 5 4/7

5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Chapter 3: How to identify the Maintenance reminder for the Reference Electrode? After one year from the last Reference Electrode replacement, according to the instructions given in Chapter 2, the Maintenance reminder will be displayed in the Ready screen, as it follows: Figure 11 5/7

6 After replacing the Reference Electrode, from Ready screen, press More functions button, select Quick access, select Maintenance scheduler and press Run. Select the pending action (in red) REPLACE REF. ELECT. and press the Confirm button. The Maintenance reminder will be automatically re-adjusted to remind you, after one year, that the Reference Electrode replacement has to be done again. Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 6/7

7 Figure 18 Actions required: Check the installation date of reference electrodes on all of your OMNI C, cobas b 121 and cobas b 121<BGE> 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 7/7