Your glucose meter power be keeping secrets from you.

If and when you see a subject matter on the screen alerting you to a "High" blood sugar, the m plausibly knows much information technology's telling you, as in the accurate nonverbal value connected with that warning. But the device makers decided that we don't motive that information…

This came to light (in our brains, at least) following the March 25 proclamation that almost two million LifeScan OneTouch VerioIQ meters were being recalled across the globe.

LifeScan issued warnings along three brands of its OneTouch meters, totaling over 1.8 million meters worldwide! About 90,000 of its hot VerioIQ meters here in the U.S., component part of the 1.2 million of those meters sold globally, and two brands oversubscribed outside US: the OneTouch® Verio®Pro consumer meter and VerioPro+ professional meter.

The intellect for the call in? The metre software isn't properly registering extremely high line of descent sugars. At a certain point the measure shuts down with no warning and without alertness you to the hyperglycemic danger. The number you take up to reach for this to happen: 1024 mg/deciliter (or 56.8 mmol to those outside the U.S.)!

Geez, the number 1024 is oddly specific…

Like many meters, LifeScan's units only show a numerical respect for anything between 20-600, while anything outside that range just displays an "Extreme Low Glucose (below 20 mg/decilitre)" or "Extreme Falsetto Glucose (above 600 mg/dL)" message.

Thus, who would have sentiment the time in reality knows when you've tipped past 1023?

Maybe our meters are smarter than we give them credit for, despite the fact that they're sometimes a bit slay thanks to that pesky +/-20% truth standard that we don't think is good.

Why No Numbers?

LifeScan confirmed our suspicions: Yes, their meters can track your blood glucose's nonverbal value clear up to 1023, but once it hits the 1024 mark it goes all wonky because of a software package malfunction and just shuts off. Or, in the case of the two models outside the U.S. impacted by the recall, it may get unoriented and exhibit the difference 'tween your true numerical value and the 1023, meaning you might see a 40mg/dL when you're really that amount finished the 1023 mark (!).

Yikes!

Anything 'tween 600 and 1023 calm down registers correctly, and the exploiter sees a warning that they'ray high and call for to take action.

LifeScan spokesman David Detmers says the reason the meter doesn't share the numerical value at 600 or above is unsophisticated: The company can't guarantee accuracy to the duplicate standard as they butt with anything 'tween 20 and 600.

Meter and strip accuracy is of course a touchy topic for the Diabetes Community, and we're e'er clamoring more or less improving accuracy on the far side the existing error margin — especially for "mid-range" results where a 20 or 30 point difference can easily cause us to make an insulin dosing error.

Once you enter upon the extremely higher death, the precision ISN't as keyed in and so companies can't live held to the same accuracy standards, Detmers says. That's why the precise numbers are not displayed.

Not all glucose meters are created the same, only interestingly, none seem to display specific numbers in the very treble chain. According to some of the other big meter manufacturers:

  • Abbott meters reveal numbers from 20-500 Mg/dL, before switching to just displaying "Hullo" or "Lo" messages.
  • AgaMatrix and Acetylsalicylic acid meters display from 20 to 600, and in Bayer's case we're told there's no internal tracker, substance the meters don't flat register exact values on the far side that range.
  • Roche Accu-Chek meters also display from 20-600 (its Compact Plus goes down to 10 mg/dL), and the fellowship "couldn't say" if any numerical values are recorded internally outside that range (?)
  • ReliOn meters too range from 20-600 mg/dL, with the meters displaying "Lo" and "Howdy" messages outside the range. Manufacturing details about whether the meters retain any knowledge internally about Hi denotative values wasn't clear.

While its engrossing to know which meters whitethorn retain more knowledge than they're share-out, LifeScan's Detmers put it this way about whether that numeric value is practically something we need: "You know you're high, and that's what you really need to know — whether you're at 600 Oregon 1023."

Hmm, how more times have you seen a "Screechy" on your meter and corrected accordingly, and then hours by and by once the insulin has time to work you're still in the 200 surgery 300s? I've had that umpteen multiplication, and have wondered how high I very was to begin with.

Yes, I know: the bottom line was I was too damn malodourous and required insulin. And the time warning (not to cite the crappy way I flavor at that level) is really all I much need at that point to get correcting.

Reflecting on Super-Highs

Personally, I feel like my own internal monitory would hit before the time alert if I were ever that high. Everyone's diabetes varies, and thus how we react to hyperglycemia and have symptoms isn't the same. But for me, I feel nauseous and I'll more than likely make that unquenchable thirst and beryllium frequently bathroom-bound. I'd guess if I hit the 1,000 mark, I'd be damn about DKA and probably infirmary-bound, if not there already.

Plain, many of us cringe just thinking about having a blood sugar in the 1,000s. Many PWDs experience that at diagnosis, and it's non pleasant. But, reasonable how often power an previously diagnosed PWD experience that altitudinous a BG reading? And without a time warning, how likely is it they'd check treatment?

Our own Ask D'Mine expert Wil Dubois says it's "dead possible for type 2s to get that high, but hardly common. I would think most type 1s would be well into DKA at that point. Symptoms? Non such. You'd be astounded how people can line extinct their symptoms OR apologize them. But real, most people with BGs over 1,000 are undiagnosed. One time you are diagnosed, you'd have to be jolly loose-fitting to run that high. And if you were, you probably wouldn't comprise the rather somebody World Health Organization would bother to mental testing."

We asked around in the endocrinologist circles, too, and several pointed extinct that this isn't a very likely issue for most PWDs. Dr. Yehuda Handelsman, immediate past president of the American Association of Clinical Endocrinologists (AACE) who has a private practice in San Fernando Valley, CA, agrees. He says PWDs hitting that high A level is "very rare, highly these days with the management tools we have. Why is this an issue in 2013?"

Type 2s might be more unerect to experiencing this issue, specially the elderly who might experience illness, dehydration and not be able to distinguish symptoms from those of hypoglycemia. Just still, Handelsman doesn't think anyone with a BG level of 1024 or higher would live at home checking their sugars, without experiencing symptoms of DKA.

"There's some remote, cloud possibility, and they issued the recall," he said. "But I don't think it's something that anyone with diabetes is really going to experience at home."

In a news release about the voluntary recall, LifeScan acknowledges that the likeliness of experiencing a high over 1,000 is unaccessible, but that information technology's a serious health risk requiring immediate medical attention. Zero kidding!

The issue really came to light-footed during an internal cartesian product testing session in late December 2012, and the company then conducted an extensive investigating to confirm and evaluate the scope of the issue before deciding to come back the three affected products. In Europe, there was one report of a destruction of someone using a OneTouch VerioPro meter, but it's non unencumbered whether the incident was incidental to this especial issue surgery non. The example did involve an extremely high BG above 1023 mg/dL, but the health care supplier had used and obtained an inaccurately low result. The patient subsequently died of cardiac nab. Not good.

Just LifeScan says zero "adverse events" or patient injuries have been reported in association with this misfunction hither in the States, and there's no actual evidence that the supply has wedged anyone. Whew!

Doing the Right Affair

No matter how rare this might cost, the fact that it could happen is a cause for care. So LifeScan and all the JnJ decision-makers deserve kudos for paying attention and taking connected this voluntary recall. It's obviously a bollix to business, merely despite the remote opening, they notified the FDA and opted to recall the devices.

"We are being responsible, putting enduring safety device first, just also trying to non unduly appal patients and cause panic," Detmers said.

LifeScan says production is temporally halted on those meters, and it's already formulated a software correction that is being validated before manufacturing and distribution resumes. The company doesn't acknowledge when that will restart.

Only clearly they don't want us to freak out over this — if you use a VerioIQ, you can hold open using it safely if you want, just equal very aware of when you'atomic number 75 very high. OK, and if your metre goes dark and reboots with a set-up prompt, you mightiness be crazy-high and should probably do something about it.

Anyone exploitation one of the effected meters is bucked up to contact LifeScan directly at (800) 717-0276 or online at www.onetouch.com for more selective information, and to find away how to get a replacement meter with the intrinsic make.