Ypsomed MyLife Pura

Device Name:MyLife Pura
Manufacturer:

OBL: Ypsomed Distribution AG, Brunnmattstrasse 6, 3401 Burgdorf, SWITZERLAND.

OEM: Bionime Corporation, 100 Sec 2, Daqing Street, South District, Taichung City 40242, TAIWAN PRC.

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
Assessment: The technology used in the Ypsomed MyLife Pura, to measure blood glucose, has passed in two validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3570840/pdf/dst-06-1060.pdf.

15197:2003 - Pass General population

15197:2013 - Pass General population

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: www.ncbi.nlm.nih.gov/pmc/articles/PMC3876330/pdf/dst-07-1522.pdf.

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

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.

15197:2003 - Pass General population

15197:2013 - Pass General population