title: [Are blood glucose analyzers safe? Experiences of the BfArM based on all notifications received until end of 2005].
abstract: Since implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVD Directive), issues and field corrective actions on in vitro diagnostic medical devices (IVDMD) have to be reported to the national competent authorities. In Germany these are the BfArM and the Paul Ehrlich Institute; the latter is responsible for Annex II products used for immune hematology, tissue typing and infectiology testing. Between the beginning of 1999 and the end of 2005 BfArM received n=653 notifications on IVDMD. From these n=128 concerned analyzers and sensors (test strips) for self monitoring of blood glucose. A similar quantity of cases was reported by users and manufacturers (44.5%). In n=31 of these cases a product defect was not confirmed after the investigation of the products by the manufacturers. Product failures were confirmed in n=35 cases. The remaining cases were caused by user errors (n=29) or the data were inconclusive (n=33), predominantly because the products were not or only partly available for investigation by the manufacturers. In those cases where product failure had been verified n=24 affected the sensors (test strips) and n=11 the analyzers. Corrective actions were performed by the manufacturers in n=34 cases. From these n=27 were cases in which a product failure had been detected. However, in n=7 cases the investigations of the manufacturers were followed by preventive corrective actions because the manufacturers became aware of potential causes of future product failures. The obtained results and experiences since 1999 show that the governmental system for post-marketing surveillance of products for self testing of blood glucose is an established tool to ensure product safety. Regarding the proportion of notifications concerning these over the counter (OTC) products, it becomes obvious that they are a focus for action for the competent surveillance authorities.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. r.siekmeier@bfarm.de
authors.forename: R
authors.initials: R
authors.lastname: Siekmeier
authors.forename: J
authors.initials: J
authors.lastname: Lütz
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data*; D005858:Germany; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011934:Reagent Strips
chemical_list: D011934:Reagent Strips