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Ascensia Elite XL (Bayer)

Device Name:Elite XL
Manufacturer:Sole: Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 51368 Leverkusen, GERMANY.
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:Discontinued but still available
Description: The Ascensia Elite XL (Bayer) is a non-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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

The technology used in the Ascensia Elite XL (Bayer), to measure blood glucose, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.

Validation Publications

Diaw CS, Piol N, Urfer J, Werner D, Roth-Kleiner M. Prospective evaluation of three point of care devices for glycemia measurement in a neonatal intensive care unit. Clin Chim Acta. 2013 Oct 21;425:104-8. Epub: 2013 Jul 29. doi: 10.1016/j.cca.2013.07.021. PMID: 23906797.

- Fail Neonates

15197:2003 - Fail Neonates

Relevant Publications

Roth-Kleiner M, Stadelmann Diaw C, Urfer J, Ruffieux C, Werner D. Evaluation of different POCT devices for glucose measurement in a clinical neonatal setting. Eur J Pediatr. 2010 Nov;169(11):1387-95. Epub: 2010 Jun 24. doi: 10.1007/s00431-010-1243-2. PMID: 20574734.

Retrospective study with ISO 15197:2003 criteria applied to results, on neonates, recorded over 1 year. The authors claim that the device tended to overestimate glycaemia values; however the application of protocol criteria is dependent on the protocol procedure being followed precisely.