March 25, 2013

Verio Recall

LifeScan has announced a voluntary removal and replacement of the OneTouch® Verio®IQ blood glucose meter, effective immediately.

The reason:

We have recently determined that at extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch® Verio®IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 600 mg/dL” as intended. 
I think that there might be other issues at 1,024 but YDMV. At any rate see the details and act accordingly. Maybe most important of acting accordingly,  is to stay out of the extremely high range.

6 comments:

Scott S said...

J&J has lost my business and its recent nonstop stream of recalls and profits-above-all-else also makes me question whether this can really be the same company that set the benchmark for crisis management in its response to the Tylenol poisoning tampering incident 30 years ago. Aside from an endless stream of recalls in 2011-2012, ore recently, J&J been sloppy and ineffective in its handling of many of its recent recalls. Although their new product line has some potential, I think the company needs to clean up its act. Thanks for sharing word on this!

Anonymous said...

"I think that there might be other issues at 1,024 but YDMV". Haha...agreed. I wasn't aware that there were any meters for home use that even went that high. I thought they all stopped at 600mg/dL.

Bennet said...

Apparently it does High and Very high.

Interesting perspective as always Scott.

I am not overly sweating this recall. I have no idea why they went with second level of high and if that is a new regulatory requirement of something the tossed in a a a value ad.

As we move to more accurate strips based on the new ISO it seem logical that there are some issues discovered in post market real world conditions. I would rather see some issues and recalls than not doing the post market followup.

Scott E said...

I'm surprised as well that it quits at 1024 mg/dl -- and that leads me to wonder that if it can MEASURE a blood glucose of, say, 995, why doesn't it display 995? I figured meters (in general) could only measure to a particular number, after which it reported "High".

To Scott S's comment, I'm really curious as to how much of J&J's culture has made it to Animas, or if Animas still operates as its own company with it's own guiding principles. Having meters not perform properly is no big deal, but if cost-cutting measures or quality-control shortcuts are taken with insulin pumps, that definitely is cause for concern.

Bennet said...

So assuming this is the 2013 ISO standard strip and therefor +/- 15% 1024 is approximately 875 - 1175.

I am much more interested in the meter in normal ranges and the worked I hear about this meter is positive from users.

Bennet said...

So assuming this is the 2013 ISO standard strip and therefor +/- 15% 1024 is approximately 875 - 1175.

I am much more interested in the meter in normal ranges and the worked I hear about this meter is positive from users.