Blood glucose meter may be lethal Roche says "no need to recall"

The U.S. Food and Drug Administration (FDA) has issued defect warnings three consecutive times. Glucose dehydrogenase (GDH-PQQ) glucose meters or test strips may cause abnormal hypoglycemia, coma and even death.

In August 2009, the FDA issued another warning. Because from 1997 to 2009, the FDA has received 13 fatal reports.

Nevertheless, this does not prevent the use of this technology in foreign-funded blood glucose meter sales in China.

In China, some dealers of blood glucose meters said that as early as around 2008, many adverse incidents caused by the above problems occurred. A person familiar with the matter told the Times Weekly reporter: Roche's internal diagnosis has long found this defect, and it has also had a medical accident in China. Today, it is still pushing for the introduction of a new type of blood glucose meter test strip. For the original blood glucose meter, Roche said that there is no need to recall it.

On March 5th, at the "Advanced Forum for Optimizing Hospital Equipment Management and Blood Glucose Monitoring Equipment", Mr. Zhang Wei, Director of the Health Care Department of Roche Diagnostics (Shanghai) Co., Ltd. disclosed that Roche is making efforts to push forward with new technology. The test strips will be marketed and Roche will use the more advanced glucose dehydrogenase technology (GDH-MUT) to diagnose the excellent Jinrui blood glucose test strips to be launched in China.

Roche's blood glucose meter is still the top brand FDA notice that the GDH-PQQ technology will react with certain non-glucose sugars such as maltose, galactose, and xylose, resulting in falsely high blood glucose readings. If the patient is treated according to this pseudo-high value, it may cause abnormal hypoglycemia (hypoglycemia), coma, and even death.

FDA received 13 reports of deaths associated with GDH-PQQ blood glucose test strips, all of which were disturbed by maltose or other non-glucose sugars. FDA listed manufacturers involved in this technology include: Roche Diagnostics, Abbott Diabetes Health, Home Diagnostics, etc.

The FDA's warning once caught the attention of China. The reporter checked the documents of the national supervisory department and found that in September 2007, the State Food and Drug Administration issued a warning on the safety warning of blood glucose monitoring errors caused by the continuous release of sugar therapeutics by the US FDA, and issued another warning in September 2009: The use of GDH-PQQ glucose monitoring products for glucose dehydrogenases has been cautioned. The Ministry of Health issued in August 2009 a notice to strengthen the management of portable blood glucose monitors for clinical use. GDH-PQQ technology blood glucose meter.

However, Roche blood glucose meters are still used in many departments such as the Endocrinology of many of the top three hospitals.

It is understood that in many top-three hospitals, Roche's blood glucose meter is one of the first brands to be used in Chinese patients. At present, China's market for blood glucose meters, foreign brands accounted for 90% of the absolute share of sales, of which Roche blood glucose meter sales accounted for about one-third, second, slightly lower than Johnson & Johnson. Behind the two are Bayer, Abbott and others.

The relevant departments of the state have already reported so intensively. Why does the GDH-PQQ technology blood glucose meter still flow into the top three hospitals through various channels?

Professor Wang Yanfei, deputy director of the Diabetes Research Department of the First People's Hospital Affiliated to Shanghai Jiaotong University, has been engaged in research on blood glucose monitoring. He told the Times Weekly reporter: "The blood glucose meter is deadly, but it is anecdotal that the accident has not been discovered in China."

Professor Weng Jianping, a deputy dean of the Third Affiliated Hospital of Sun Yat-sen University and an endocrinologist, also said: “No accidents have been heard. The probability of this phenomenon is very small.”

Roche's remarks are ridiculing whether Roche's blood glucose meter may be fatal in foreign countries and is safe in China. Times Weekly spent a lot of energy connecting patients who used Roche blood glucose meters.

Ms. Zhang from Beijing has just got diabetes. She bought a Roche blood glucose meter near the Chaoyang Hospital and Hechunshou Pharmacy. When she checked her fasting in the morning, she used the family's Roche meter to check it out for 5, and went to the hospital to do a biochemical check of 7.3. This makes Ms. Zhang very confused.

Another patient, Mr. Zhou, performed tests on Roche and Johnson's blood glucose meters, respectively. The results obtained were 8.4 and 7.6, respectively.

"Glucose is not blood pressure, or it is the most accurate to go to the hospital to do big things." Experts have long pointed out that the blood sugar level is a reading that is affected by too many factors.

One of the situations is that the bias caused by the test strips is ignored by many patients. According to the type of enzyme involved in the reaction, the glucose meter is mainly divided into glucose oxidase blood glucose meter (Johnson, Bayer-based) and glucose dehydrogenase blood glucose meter (Roche, Abbott-based). Glucose oxidase is easy to combine with oxygen, resulting in deviations in the results, more backward; glucose dehydrogenase technology is not interfered by blood or oxygen molecules in the air, but one type of GDH-PQQ may cause measurement errors due to technical defects.

A doctor from the Department of Endocrinology of Guangdong Provincial Hospital told the reporter: “I’ve heard of this. I have a patient friend from Jiangsu Province who became ill and became ill. After measuring with a Roche blood glucose meter, I adjusted my medication according to the value. I was dizzy and uncomfortable. When I went to the hospital's laboratory for comparison and consultation, I found that the values ​​were very variable. I don't know if it was a test strip."

Another dealer of the blood glucose meter said that the blood glucose meter of the GDH-PQQ technology had an accident.

In 2008, Wang Hao (a pseudonym) had investigated the rumors of medical accidents caused by GDH-PQQ dehydrogenase technology.

“The Roche blood glucose meter really did something. According to some colleagues from our company in Tianjin, Shanghai, Hunan, and Hubei, this was indeed the case,” he told the Times Weekly reporter.

Wang Hao disclosed: "At that time, most hospitals received the documents and mentioned that when using GDH-PQQ dehydrogenase detection test strips in some hospitals, they were prone to larger detection errors. All clinical departments were required to pay attention to whether or not the patients used sugar before. Drugs. The documents were issued by the National Health Department and the Drug Administration and sent to provincial, prefectural and municipal hospitals."

He also told reporters: "At the time, this incident had a great impact on Roche. Many hospital doctors were concerned that 50% of clinically used blood glucose meters were replaced by Johnson, Bayer and Abbott."

The reporter immediately contacted the Shanghai Center for Monitoring of ADRs. Du Wenmin, deputy director of the center, denied this.

The reporter asked the National Ministry of Health for confirmation, and the reply was that "medical devices belong to the State Drug Administration Bureau." The reply from the relevant official of the State Food and Drug Administration to the Times Weekly reporter is: The situation has been under monitoring and statistics, but no adverse event report has been received.

The reporter immediately sought confirmation from Shanghai Roche. Xu Chao, director of public relations at Roche, seemed to be ingenious: "China's drug administration has not received any reports of adverse events."

"Why didn't we have a caution statement for Chinese consumers?"

Her reply is: “The Roche blood glucose monitor has clearly stated in all product specifications since 2000 that the maltose interfered with glucose measurement by glucose dehydrogenase technology.”

She further pointed out: “In the case of the FDA warning, only diabetics who have received intravenous infusion of immunoglobulin therapy have potential problems. According to our statistics, diabetic patients who use intravenous infusion of immunoglobulin therapy only account for diabetic patients. 1% of the total."

Xu Chao said that since the FDA issued a notice, “Roche has taken immediate actions and has repeatedly reminded doctors in the process of assisting hospitals in setting up blood glucose meter testing standards. Through written information exchanges and professional actions of the company’s business units, Professional medical personnel and relevant government agencies have conducted active communication of information to ensure that health care professionals and patients with diabetes are better able to understand what Roche's blood glucose monitoring methods are available and select the blood glucose monitoring equipment that best suits the patient's condition.”

The lack of law creates regulatory loopholes Whether or not an accident occurs, the most innocent is the patient's life. Even if it is as small as 1% as described by Roche, it is 100% disaster for the patient.

"Diabetes is a digital disease. Blood glucose monitoring has lost a lot of attention, and it has been a thousand miles away." Professor Guo Xiaoyun, director of the Department of Endocrinology at the First Hospital of Peking University, once called for this.

Unfortunately, several well-known brands of blood glucose meters have experienced an excessive amount of time. The world’s top-ranking Johnson & Johnson’s “Wenhao” and “Shengling” blood glucose meters were also ordered by the FDA to be recalled worldwide in 2005 due to measurement unit problems; Bayer's blood glucose meter was also due to measurement error in the United States in 2007. Was recalled.

So is Roche's potentially fatal blood glucose meter having a recall plan?

"Glucose meters with different physical and chemical technologies have their own advantages and disadvantages. All blood glucose test strips on the market currently have interference factors." Xu Chao said that there is no recall plan.

Previously, some experts said: "There are still a small number of foreign medical device manufacturers, and after discovering that their products have important flaws, they should be recalled immediately in foreign countries. However, in China, it may be an incomplete recall or incomplete compensation. No medical device. "Recall Management Measures" and other regulations, and it does not recall you can not say it is illegal."

The Governing Measures for Monitoring and Reassessment of Medical Device Adverse Events and the Administrative Measures for Recall of Medical Devices have been brewing for a long time and are still being solicited for comments and amendments. To date, no formal documents have been issued yet, which also creates loopholes in supervision.

In addition, according to Xu Chao, Roche diagnosed this year's newly-listed Jinrui excellent blood glucose test strips, “after international standards for anti-interference testing. The test strips are immune to maltose, xylose and fructose, and are not exposed to air or oxygen in the blood. Interference, providing accurate blood glucose results."