Terumo Medisafe Mini

Device Name:

Medisafe Mini

Manufacturer:

Distributer: Terumo Europe NV, Researchpark Haasrode 1520, Interleuvenlaan 40, 3001 Leuven, BELGIUM.

Other: Terumo Corporation, 2-44-1 Hatagaya, Shibuya-ku, Tokyo 151-0072, JAPAN.

Other: Terumo Medical Corporation, 2101 Cottontail Lane, Somerset, NJ 08870, 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:

Available Currently

Description:

The Terumo Medisafe Mini is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Terumo Medisafe Mini, to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

Wada Y, Nakamura T, Kaneshige M, Takahashi S, Fujinaga H, Tsukamoto K, Ito Y, Sago H. Evaluation of two glucose meters and interference corrections for screening neonatal hypoglycemia. Pediatr Int. 2015 Aug;57(4):603-7. Epub: 2015 Feb 11. doi: 10.1111/ped.12543. PMID: 25441549.

Ad Hoc protocol Neonates

Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.

15197:2013 - Fail General population

15197:2003 - Fail General population