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Ascensia Breeze 2 (Bayer)

Device Name:Breeze 2
Manufacturer:Sole: Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 51368 Leverkusen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Description: The Ascensia Breeze 2 (Bayer) is a clinically validated and 1-star blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

The technology used in the Ascensia Breeze 2 (Bayer), to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationOlder clinical validation; recent protocol
Institute of Health Economics (CA)General useNo evidence provided
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Fail Using insufficient blood samples (n=31)

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

FDA:2016H - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2007/59

SKUP. Report from the evaluation SKUP/2007/59: Breeze 2 (Bayer Healthcare), a system for blood glucose measurement. Bergen, Norway: SKUP; 2007. 52 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

Relevant Publications

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Performance with haematocrit variation unstable.