Your glucose meter might be keeping secrets from you.
If and when you see a message on the screen alerting you to a "High" blood sugar, the meter probably knows more than it's telling you, as in the exact numerical value associated with that warning. But the device makers decided that we don't need that information...
LifeScan issued warnings on three brands of its OneTouch meters, totaling over 1.8 million meters worldwide! About 90,000 of its popular VerioIQ meters here in the U.S., part of the 1.2 million of those meters sold globally, and two brands sold outside the States: the OneTouch® Verio®Pro consumer meter and VerioPro+ professional meter.
The reason for the recall? The meter software isn't properly registering extremely high blood sugars. At a certain point the meter shuts down with no warning and without alerting you to the hyperglycemic danger. The number you have to reach for this to happen: 1024 mg/dL (or 56.8 mmol to those outside the U.S.)!
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Geez, the number 1024 is oddly specific...
Like many meters, LifeScan's units only show a numerical value for anything between 20-600, while anything outside that range just displays an "Extreme Low Glucose (below 20 mg/dL)" or "Extreme High Glucose (above 600 mg/dL)" message.
So, who would have thought the meter actually 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 off thanks to that pesky +/-20% accuracy standard that we don't think is good enough.
Why No Numbers?
LifeScan confirmed our suspicions: Yes, their meters can track your blood sugar's numerical value all the way up to 1023, but once it hits the 1024 mark it goes all wonky because of a software malfunction and just shuts off. Or, in the case of the two models outside the U.S. impacted by the recall, it may get confused and display the difference between your actual numerical value and the 1023, meaning you might see a 40mg/dL when you're really that amount over the 1023 mark (!).
Anything between 600 and 1023 still registers correctly, and the user sees a warning that they're high and need to take action.
LifeScan spokesman David Detmers says the reason the meter doesn't share the numerical value at 600 or above is simple: The company can't guarantee accuracy to the same standard as they can with anything between 20 and 600.
Meter and strip accuracy is of course a touchy topic for the Diabetes Community, and we're always clamoring about improving accuracy beyond 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 get into the extremely higher end, the precision isn't as keyed in and so companies can't be 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, but interestingly, none seem to display specific numbers in the very high range. According to some of the other big meter manufacturers:
- Abbott meters display numbers from 20-500 mg/dL, before switching to just displaying "Hi" or "Lo" messages.
- AgaMatrix and Bayer meters display from 20 to 600, and in Bayer's case we're told there's no internal tracker, meaning the meters don't even register exact values beyond that range.
- Roche Accu-Chek meters also display from 20-600 (its Compact Plus goes down to 10 mg/dL), and the company "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 "Hi" messages outside the range. Manufacturing details about whether the meters retain any knowledge internally about Hi numerical values wasn't clear.
While its interesting to know which meters may retain more knowledge than they're sharing, LifeScan's Detmers put it this way about whether that numerical 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 or 1023."
Hmm, how many times have you seen a "High" on your meter and corrected accordingly, and then hours later once the insulin has time to work you're still in the 200 or 300s? I've had that many times, and have wondered how high I really was to begin with.
Yes, I know: the bottom line was I was too damn high and needed insulin. And the meter warning (not to mention the crappy way I feel at that level) is really all I practically need at that point to get correcting.
Reflecting on Super-Highs
Personally, I feel like my own internal warning would hit before the meter alert if I were ever that high. Everyone's diabetes varies, and thus how we react to hyperglycemia and experience symptoms isn't the same. But for me, I feel nauseous and I'll more than likely have that unquenchable thirst and be frequently bathroom-bound. I'd guess if I hit the 1,000 mark, I'd be damn close to DKA and probably hospital-bound, if not there already.
Obviously, many of us cringe just thinking about having a blood sugar in the 1,000s. Many PWDs experience that at diagnosis, and it's not pleasant. But, just how often might an previously diagnosed PWD experience that high a BG reading? And without a meter warning, how likely is it they'd delay treatment?
Our own Ask D'Mine expert Wil Dubois says it's "absolutely 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? Not so much. You'd be surprised how people can tune out their symptoms or rationalize them. But really, most people with BGs over 1,000 are undiagnosed. Once you are diagnosed, you'd have to be pretty sloppy to run that high. And if you were, you probably wouldn't be the kind of person who would bother to test."
We asked around in the endocrinologist circles, too, and several pointed out 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 uncommon, extremely these days with the management tools we have. Why is this an issue in 2013?"
Type 2s might be more prone to experiencing this issue, particularly the elderly who might experience sickness, dehydration and not be able to distinguish symptoms from those of hypoglycemia. But still, Handelsman doesn't think anyone with a BG level of 1024 or higher would be at home checking their sugars, without experiencing symptoms of DKA.
"There's some remote, obscure 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 likelihood of experiencing a high over 1,000 is remote, but that it's a serious health risk requiring immediate medical attention. No kidding!
The issue actually came to light during an internal product testing session in late December 2012, and the company then conducted an extensive investigation to confirm and evaluate the scope of the issue before deciding to recall the three affected products. In Europe, there was one report of a death of someone using a OneTouch VerioPro meter, but it's not clear whether the incident was related to this particular issue or not. The case did involve an extremely high BG above 1023 mg/dL, but the healthcare provider had used and obtained an inaccurately low result. The patient subsequently died of cardiac arrest. Not good.
But LifeScan says no "adverse events" or patient injuries have been reported in association with this malfunction here in the States, and there's no actual evidence that the issue has impacted anyone. Whew!
Doing the Right Thing
No matter how rare this might be, the fact that it could happen is a cause for concern. So LifeScan and all the JnJ decision-makers deserve kudos for paying attention and taking on this voluntary recall. It's obviously a blow to business, but despite the remote possibility, they notified the FDA and opted to recall the devices.
"We are being responsible, putting patient safety first, but also trying to not unduly alarm patients and cause panic," Detmers said.
LifeScan says production is temporally halted on those meters, and it's already developed a software correction that is being validated before manufacturing and distribution resumes. The company doesn't know when that will restart.
But clearly they don't want us to freak out over this -- if you use a VerioIQ, you can keep using it safely if you want, just be very aware of when you're very high. OK, and if your meter goes dark and reboots with a set-up prompt, you might be crazy-high and should probably do something about it.
Anyone using one of the effected meters is encouraged to contact LifeScan directly at (800) 717-0276 or online at www.onetouch.com for more information, and to find out how to get a replacement meter with the built-in fix.