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- Computerized Adverse Event Detection
- Food and Drug Administration (FDA)
- United States Federal Government
Potentially fatal errors with GDH-PQQ [glucose dehydrogenase pyrroloquinoline quinone] glucose monitoring technology.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 13, 2009.
This public health notification raises awareness of the potential for falsely elevated blood glucose readings in patients using therapeutic products containing certain non-glucose sugars.
Journal Article > Study
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.
Brajovic S, Piazza-Hepp T, Swartz L, Pan GD. Pharmacoepidemiol Drug Saf. 2012;21:565-570.
The Food and Drug Administration is piloting a new system that allows triggered reporting of suspected adverse drug events, with data automatically supplied from existing electronic medical record systems. This study evaluates the quality of such reports and identifies areas where the reports could be improved.