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Roche Accu-Chek Aviva Expert

Device Name:Accu-Chek Aviva Expert
Manufacturer:Sole: Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Roche Accu-Chek Aviva Expert is a clinically validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:

The technology used in the Roche Accu-Chek Aviva Expert, to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. However, it was also assessed in another study but the results have not been published and cannot be verified.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhile a clinical validation is claimed, it cannot be checked properly.
TÜV Rheinland NederlandGeneral useUnpublished internal data
Institute of Health Economics (CA)General useNo evidence provided

Validation Publications

Jendrike N, Baumstark A, Pleus S, Liebing C, Beer A, Flacke F, Haug C, Freckmann G. Evaluation of Four Blood Glucose Monitoring Systems for Self-Testing with Built-in Insulin Dose Advisor Based on ISO 15197:2013: System Accuracy and Hematocrit Influence. Diabetes Technol Ther. 2018 Apr;20(4):303-13. doi: 10.1089/dia.2017.0391. PMID: 29664706.

15197:2013 - Fail General population