重要訊息：Accu-Chek® Guide 智航血糖機可能存在與電源有關的問題
Important information on Accu-Chek® Guide blood glucose meters potentially having power related issues
Accu-Chek®Guide智航血糖機
安全通知
香港 , 2019年10月22日
重要訊息：Accu-Chek®Guide智航血糖機可能存在與電源有關的問題
親愛的羅氏血糖機用戶，
羅氏公司致力於提供高品質的產品及服務予我們客戶，並承諾對於任何可能影響我們產品使用的問題會誠實告知。秉持這個精神，今天我們需要通知閣下，根據我們持續的品質監控和市場監管，我們發現Accu-Chek®Guide智航血糖機可能出現以下與電源有關的問題：
•顯示E-9錯誤訊息（指示需要更換電池）
•無預期顯示電池電量不足符號
•電池壽命過短
•無法開機
若使用者發生有上述電源問題可能會導致暫時無法使用血糖機而有可能延遲其醫療處置。由於病人的健康安全是羅氏公司的首要考量，我們希望與您及使用者溝通以下的事項，以確保優化電池壽命的性能。
在此，我們還想與您說明有關如何處理Accu-Chek®Guide羅氏智航血糖機電源問題。此問題可能發生在機器序號低於XXX11000001的血糖機，其中“ XXX”是序號的首3位數字。機器序號可以在血糖機背面找到，如右圖的紅色長方格所示。
請注意以下事項，以優化電池的壽命以及如何處理電源問題的建議:
• 提醒：
1.請常備備用電池。
2.電池壽命可能因溫度和電池製造商等因素而異。
3.有可用的備用血糖檢測工具。
• 若血糖機在開機狀態時顯示E-9錯誤訊息或電池電量低符號：
1.將血糖機移至溫度更適合的環境中，以確保最佳的電池壽命性能。
2.關閉血糖機，然後重新啟動血糖機。
3.如果問題仍然存在，請執行以下操作以重設血糖機：
- 取出電池，
- 按住開關/設定/「OK」鍵至少2秒，
- 重新放入電池。
4.如果在重設血糖機後仍然出現問題，請按照使用者手冊中的說明更換2顆全新電池，例如樂聲牌(Panasonic)。
5.如果更換電池不能解決問題，請聯繫本公司客服專線+852 2485 7512 (週一至週五9:00-12:00/13:30-17:30)。
• 血糖機無法開機或電池壽命過短：
1.將血糖機移至更適合的環境中，以確保最佳的電池壽命性能。
2.執行以下操作來重設血糖機：
- 取出電池，
- 按住開關/設定/「OK」鍵至少2秒，
- 重新放入電池。
3.如果在重設血糖機後仍然出現問題，請按照使用者手冊中的說明更換2顆全新電池，例如樂聲牌(Panasonic)。
4.如果更換電池不能解決問題，請聯繫本公司客服專線+852 2485 7512 (週一至週五9:00-12:00/13:30-17:30)。
我們已經對這個問題進行徹底調查找出根本原因，並且已經開始執行適當的矯正措施。相關資訊亦已通知衛生署、醫管局、專業醫護人員、分銷及零售商，並已上載於https://www.accu-chek.com.hk。假如您對於Accu-Chek®Guide智航血糖機的使用有疑問，或是有進一步的問題，請聯絡本公司客戶服務熱線+852 2485 7512 (週一至週五 9:00-12:00/13:30-17:30)。真誠感謝閣下對此事件的關注。
此致
羅氏診斷(香港)有限公司
健康護理部
Hong Kong, 22 Oct 2019
Important information on Accu-Chek® Guide blood glucose meters potentially having power related issues
Dear valued customers,
At Roche Diabetes Care, we strive for highest quality of our products and services and are committed to keeping you informed as soon as there is a potential issue you should be aware of. This is why we would like to inform you today about an issue that might occur in Accu-Chek® Guide blood glucose meters. As part of our ongoing quality monitoring and market surveillance processes, we have identified that Accu-Chek® Guide blood glucose meters may potentially:
- Display E-9 Errors (indicating batteries need to be replaced)
- Show unexpectedly the low battery icon
- Have short battery life
- Not power on
Power issues such as those listed may result in a temporary meter unavailability for the user. Failure to test could cause a delay in therapy decisions and may potentially lead to a serious medical condition. As patient safety is our primary concern, we want to communicate to you the below mentioned notices to ensure optimal battery life performance.
In addition, we would also like to provide you with specific instructions on how to handle power issues of Accu-Chek® Guide blood glucose meters. This applies to meters with the defined serial numbers below XXX11000001, where "XXX" is the first 3 digits of the serial number. The serial number can be found on the back of the meter, indicated by the red rectangle in the photo below.
Please find below the following warning and important notices to ensure optimal battery life performance and recommendations on how to handle power issues.
- Warning:
- Always have a spare set of batteries.
- Battery life may vary due to factors such as temperature and battery manufacturer.
- Have a back-up testing method available.
- If the meter is powered on and displaying an E-9 error or low battery icon:
- Move the meter to a more moderate environment to ensure optimal battery life performance.
- Turn the meter off, then turn the meter back on.
- If the problem persists, perform a meter reset by doing the following:
- Remove the batteries
- Press and hold the Power/Set/OK button for at least 2 seconds
- Reinsert the batteries.
- If the problem still occurs after performing a meter reset, then replace the batteries with new ones according to the instructions in the user manual. Use high quality batteries in the meter, such as Panasonic.
- If replacing the batteries does not correct the situation, please contact our Roche Diabetes Care Customer Care line at +852 2485 7512 to obtain further support.
- If the meter will not power on or has short battery life:
- Move the meter to a more moderate environment to ensure optimal battery life performance.
- Perform a meter reset by doing the following:
- Remove the batteries,
- Press and hold the Power/Set/OK button for at least 2 seconds,
- Reinsert the batteries.
- If the problem still occurs after performing a meter reset, then replace the batteries with new ones according to the instructions in the user manual. Use high quality batteries in the meter, such as Panasonic.
- If replacing the batteries does not correct the situation, please contact our Roche Diabetes Care Customer Care line at +852 2485 7512 to obtain further support.
We have thoroughly investigated this issue to identify the root cause and have already started to implement the appropriate corrective measures. This includes design improvements to make the meters more robust against battery performance issues.
Your national competent authority, healthcare professionals and distributors and retailers have been informed about this field action. This information is also available on our website, www.accu-chek.com.hk.
We sincerely apologise for any inconvenience this may cause and hope that the enhanced handling information provided with this communication supports you in a safe, reliable and satisfactory use of the Accu-Chek® Guide blood glucose meter.
Please call our Roche Diabetes Care Customer Care line +852 2485 7512 during office hours (Mon-Fri 9:00am-12:00pm, 1:30pm-5:30pm), if you need any additional advice on the operation of Accu-Chek® Guide blood glucose meters or have any further questions or concerns. It is through the careful monitoring of customer reports that we are able to identify issues and implement solutions. We appreciate your time and attention to this important notification.
Kind regards,
Diabetes Care
Roche Diagnostics (Hong Kong) Limited