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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.

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.