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U.S. Department of Health and Human Services

Safety

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Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products

Audience: Endocrinologists and other healthcare professionals, clinical laboratory managers, risk managers and patients

[UPDATE 04/22/2008] Fatal Iatrogenic Hypoglycemia: falsely elevated blood glucose readings with a point-of-care meter due to a maltose-containing intravenous immune globulin product. Following receipt of the index case, FDA conducted an investigation. This review represents the final report of that investigation.

[Posted 11/10/2005] FDA notified physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. There have been reports of the inappropriate administration of insulin and consequent life-threatening/fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. A preliminary listing of U.S. products that may cause glucose test interference is provided.

[April 17, 2008 - Final Report - FDA/CBER/CDRH]
[November 09, 2005 - Important Safety Information - FDA/CBER]
[November 09, 2005 - Reminder Notice - FDA/CDRH]