Replies to post #94447 on Decision Diagnostics Corp (DECN)

[Luka Brasi]

I hate to admit it but without any verifiable proof it is just rumor. I want to believe that this distributor has the CE designation on their site as an indication of CE approval and not just a copy/paste error. Why doesn’t the EU have a searchable database for CE products? I mean they make you apply for approval why not have a public database?

[IPwatcher]

NO WAY that thing ever even passes the ESD requirements, (even if the glucose meter itself did!) for any CE mark, let along and IVD one!
To say nothing of the fact that it has sharp edges that you could cut yourself on! IVD devices are supposed to be SAFE! Its a basic requirement!

Actually, I think I have hit on something rather obvious here...
Although more involved with the chemistry than the electronics and ergonomics elements of diagnostics devices, having sat through the purgatory of more FMEAs (Failure Mode effects analysis reviews), SRAs (System risk analysis which are essential requirements for any IVD product regulatory submissions) than I care to remember... Well.... some of it sticks.

On that basis I would say There is no way any IVD with those stupid exposed electrical contacts on that ridiculous strip inserter thing gets approved for anything*, anywhere in the world, let alone an IVD CE mark.

Leaving aside the ESD and cut hazards (this is a device that is routinely exposed to pathogenic substances in the course of normal intended use, remember!), it is readily apparent that the electrical effect of a finger placed on those exposed contacts would immediately either stop the device working as intended or worse, produce an erroneous result.
The simple fix (removing the contacts to within the meter housing so that they are not exposed, or encasing them in an insulating housing) would be pretty much mandated as part of the device development, long before a regulatory filing was even deemed ready for submission, let alone approved!

If there are any device engineers looking in, maybe they could comment!?

Then there is the 'cleaning' requirement. That thing is expected in the course of its normal use to be place into direct contact with pathogenic substances. That's its job.
That means you have 2 realistic options for this type of IVD device (NB it is not autoclavable like surgical tools!)
Either:
(i) Disposible. That inserter isn't! OR
(ii) Wipe clean (alcohol. bleach or similar).
And That 'inserter' POS is neither of those things!

There is no way on God's earth that thing gets a CE Mark. PERIOD!


And even if one was issued in error, it would be withdrawn before the week was out, for the reasons stated above!

Those are NOT pictures of a REMOTELY compliant In-vitro diagnostics Device. End of!

*What they look like is 'engineering keys' used for e.g. uploading information to the Meters EPROM for cal code or programming, or as diagnostics checks, but always PRIOR TO USE and NEVER as part of a live test! Probably pulled out of the Bio Co parts bin, and used for diagnosing broken meters or similar!
What happens when they get wet with saliava sample and the test strip is completely short circuited thereby?... <shakes head!>