Important information about open vials of Accu-Chek^® Performa test strips

 

Accu-Chek^® Performa 卓越血糖試紙

安全通知

香港, 2021年7月22日

 

重要訊息: Accu-Chek^® Performa卓越血糖試紙可能存在拆封全新紙盒內之試紙瓶已開啟的問題

 

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，今天我們需要通知您，根據我們持續的品質監控和市場監管，我們發現Accu-Chek^® Performa 卓越血糖試紙瓶可能出現的極罕見情況，這些試紙瓶可能在仍處於密封紙盒中已打開。如果您在拆封全新試紙盒時，發現試紙瓶已開啟或損壞，可能會導致在血糖機上無法進行有效的血糖測量，因為打開的試紙瓶會使試紙暴露在潮濕環境中，從而損壞試紙並可能導致不準確的結果（例如正偏差或偽過高的結果）。而因不準確結果進行不適當治療可能導致不利的健康後果。

 

矯正措施和理由的描述

羅氏總公司日前收到來自美國一家醫院的客戶投訴，聲稱當要開始使用試紙時，發現試紙瓶蓋在密封的紙盒內已經開啟，會出現非預期的結果（例如正偏差或偽過高結果）。

經羅氏的調查顯示，在極罕見情況下，以下運輸過程中試紙瓶蓋可能會在密封的紙盒中打開：

這種情況可能發生在 Accu-Chek^® Performa 卓越血糖試紙，在高溫（≥45°C）下運輸和配送過程中紙盒遭到重摔或粗暴搬運。只有當這兩種條件同時存在時，此情況才有可能發生。

受到高溫和潮濕的影響，這種極罕見的試紙瓶開啟可能會影響血糖測量的準確性。

 

羅氏公司採取的行動

羅氏公司正在更新產品說明書，說明在全新未開封紙盒內試紙瓶已打開的處理。 羅氏公司將為拆封全新試紙盒時發現試紙瓶已開啟的使用者提供試紙更換服務。當您發生上述狀況，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）。

 

Accu-Chek^® Performa卓越血糖試紙使用注意事項

• 使用前務必檢查Accu-Chek^® Performa卓越血糖試紙瓶。
• 當發生以下情況，請不要使用試紙：
  • 若在拆封全新試紙盒時且完全未使用情況下試紙瓶身已開啟（如右圖所示）或已損壞
    
  • 若試紙瓶蓋沒有完全蓋上
  • 若發現試紙瓶蓋或瓶身有任何損壞
  • 若試紙瓶蓋因任何原因無法正常蓋緊
• 請勿依照使用者手冊執行品管檢測
• 如果您有任何受影響的產品，請立即處理該試紙。

在高溫（≥45°C）下運輸和配送過程中紙盒遭到重摔或粗暴搬運。只有當這兩種條件同時存在時，本公司將提供使用者在拆封全新紙盒時試紙瓶身已開啟或已損壞情況下提供試紙更換服務。當您發生上述狀況，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）。

 

本安全通知的溝通

本安全通知的相關資訊已通知衛生署及醫管局、專業醫護人員、經銷商和零售商以及 Accu-Chek^® Performa 卓越血糖試紙的使用者。

對於給您帶來的不便，我們深表歉意，並希望您的理解與合作。如果您需要有關處理Accu-Chek^® Performa卓越血糖試紙的任何其他建議或有任何進一步的問題或疑慮，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）。真誠感謝您對於此通知的協助。

 

此致

羅氏診斷(香港)有限公司

健康護理部

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Hong Kong, 22 Jul 2021

 

Important information about open vials of Accu-Chek^® Performa test strips  

 

Dear valued customers,

 

At Roche Diabetes Care, we strive for the highest quality of products and services and are committed to keeping you informed as soon as there is a potential issue of which you should be made aware. This is why we would like to inform you today about the rare occurrence of Accu-Chek^® Performa test strip vials which have opened while still in a sealed carton. If you have a test strip vial that has opened while still in a sealed carton, you may observe the inability to perform a valid blood glucose measurement on your meter, because an open vial would expose the test strips to humidity which damages the strips and could result in inaccurate results (such as positively biased, or falsely too high, results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences.

 

Description of Situation and Rationale giving rise to this corrective measure

Roche Diabetes Care has received complaints from one hospital in the United States alleging unexpected results (such as positively biased, or falsely too high, results) when using test strip vials which have opened while still in a sealed carton.

The Roche investigation showed that, in very rare circumstances, it is possible that a vial can open in a sealed carton while in transit.

This could happen to Accu-Chek^® Performa test strips, when they are shipped at elevated temperature (≥45°C or 113°F) AND when the carton is dropped or handled roughly during transit and distribution process. It is only when these two conditions occur in combination that the failure mode has been observed.

Due to the influence of high temperature and humidity this failure might affect the accuracy of the blood glucose measurement.

 

Details on affected test strips

The potentially affected test strips are

• Accu-Chek^® Performa

 

Actions taken by Roche Diabetes Care

Roche Diabetes Care is updating product labeling to clarify instructions for handling vials that have opened within sealed cartons.  Roche Diabetes Care will provide test strip replacements to users who have purchased test strip vials which have opened while still in a sealed carton.

 

Actions to be taken by users of Accu-Chek^® Performa test strips

• Users are advised to always inspect vials of Accu-Chek^® Performa test strips before use.
• Please, do not use the test strips if
  • vial is open or damaged before using the test strips for the first time,
    
  • the cap is not fully closed
  • you see any damage to the cap or vial, or
  • anything prevents the cap from closing properly.
• Please do not perform control testing as instructed in the meter manual.
• If you have any affected product, please dispose of the test strips immediately.
• Roche Diabetes Care will provide test strip replacements to users who have purchased vials that were open within the sealed carton. To obtain replacement from Roche Diabetes Care, please call our Roche Diabetes Care Customer Service: +852 2485 7512 during office hours (Mon-Fri 9:00am-12:00pm, 1:30pm-5:30pm).

 

Communications of this Field Safety Notice

Your national competent authority, healthcare professionals, distributors and retailers and users of the Accu-Chek^® Performa test strips have been informed about this field action. This information is also available on our website, www.accu-chek.com.hk.

We sincerely apologize for any inconvenience this may cause and hope for your understanding and cooperation. Please call our Roche Diabetes Care Customer Service: +852 2485 7512 during office hours (Mon-Fri 9:00am-12:00pm, 1:30pm-5:30pm), if you need any additional advice on the handling of the Accu-Chek^® Performa test strips or have any further questions or concerns. We appreciate your time and attention to this important notification.

 

Kind regards,
 

Diabetes Care 

Roche Diagnostics (Hong Kong) Limited