Boehringer Mannheim RefloLux S

Device Name:

RefloLux S

Manufacturer:

Boehringer Mannheim GmbH (now Roche), Sandhofer Strasse 116, 68305 Mannheim, Baden-Wurttemberg, GERMANY.

Other: Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Obsolete

Description:

The Boehringer Mannheim RefloLux S is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use. This device is now obsolete.

Assessment:

The technology used in the Boehringer Mannheim RefloLux S, 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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has failed a clinical validation.

Validation Publications:

Ho HT, Yeung WK, Young BW. Evaluation of "point of care" devices in the measurement of low blood glucose in neonatal practice. Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F356-359. doi: 10.1136/adc.2003.033548. PMID: 15210675. Available from: PMC1721720.

ADA:1994 - Fail Neonates (n = 57) (Note: Error < 10 %: 26.3 % (1 / 2))

ADA:1994 - Fail Neonates (n = 44) (Note: Error < 10 %: 29.5 % (2 / 2) )

CLSI:1994 - Fail Neonates (n = 57) (Note: Error ≤ 0.83 mmol/L: 68.4% (< 95 %) (1 / 2) )

CLSI:1994 - Fail Neonates (n = 44) (Note: Error ≤ 0.83 mmol/L: 88.6% (< 95 %) (2 / 2) )