Saudi Food and Drug Authority warn from using glucose test strips that use the GDH-PQQ measurement method

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Saudi Food and Drug Authority warn from using glucose test strips that use the GDH-PQQ measurement method

Warning Date
2009-12-22
Warning Reason
Correction Actions
Advices to Consumer

Saudi food and drug authority, represented by the National Center for medical devices reporting, has found through its surveillance for the quality and safety of medical devices marketed in Saudi Arabia. That there are glucose test strips that measure blood glucose in the blood by using GDH-PQQ method and since the measuring method used in these devices cannot distinguish between glucose and other non-glucose sugars, including maltose, xylose, and galactose, found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product that leads to inaccurate readings, which requires inappropriate medical intervention that may result in the patient’s life at risk.

Therefore SFDA advise healthcare providers, should refer to device labeling to confirm the used blood sugar measuring methodology, also SFDA advice laypersons to stop using those strips since there are other glucose test strip methodologies are not affected by the presence of non-glucose sugars such as: (GDH-FAD & GDH-NAD)
FOR MORE INFORMATION, PLEASE



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