DarioHealth Corp (DRIO)

[mademan552]

how about some report on competing product:


Model Number BG1
Event Date 07/07/2014
Event Type Malfunction
Event Description

I tried out the health align glucometer. It is designed to be used with an iphone, but will only work if you take the case off your phone first (poor design). Once i finally got it to work by removing the case from my phone, the battery that was included only held enough power for a single glucose test. I changed to the other battery that was included (it comes with 2), and that one also only lasted for one test. When comparing results from this meter, for both tests that i tried it read about 40 points higher than my usual meter (true-result). Looks like the ihealth align is poorly designed, inaccurate, and comes with faulty batteries. I attempted to contact the manufacturer at their toll-free phone number three times. Only once was i able to speak to someone. The other 2 times i received a recording that all their lines were busy and to leave a message.



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3932752