Consumers report glucose meter problems to FDA

Diabetes Technology and Therapeutics

Volumn 6, Issue 6, 2004, Pages 767-769

  Gutman, Steven I ^a   Fuller, Janie G ^b   Hausman, Ethan D ^a,c,d  

^a Off In Vitro Diagn Device Eval S   (United States)

^b Ctr Devices and Radiological Hlth   (United States)

^c GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALIBRATION; CONFERENCE PAPER; CONSUMER; DIABETES MELLITUS; DIAGNOSTIC ACCURACY; DIAGNOSTIC KIT; EVALUATION; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GLUCOSE ASSAY; ORGANIZATION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL;

EID: 12344302948     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2004.6.767     Document Type: Conference Paper

References (3)

1. The U.S. blood glucose strips market: diabetes glucose self-monitoring test strips market: annual utilization of test strips 2002. Dialog File Number 767. Accession Number 1022839. London: Frost and Sullivan. Available from: http://www.dialogselect.com/business/cgi/present. Accessed 09 June 2003.
2. Weitgasser R, Gappmayer B, Pichler M: Newer portable glucose meters - analytical improvement compared with previous generation devices? Clin Chem 1999;45:1821-1825.
3. International Standardization Organization: ISO/FDIS 15197:2003(E). Requirements for In Vitro Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. U.S. Technical Advisory Group for ISO/TC212. Administered by NCCLS. Wayne, PA: Global Consensus Standardization for Health Technologies.