- The U.S. Food & Drug Administration announced that a glucose meter (a.k.a. a blood sugar meter) company is issuing an important correction for its blood glucose monitoring system.
- True Metrix is the brand, and since 2014, 114 serious injuries and one death have resulted from the issue.
- Here’s what you need to know.
Monitoring blood sugar levels is a matter of life and death for some people, which is why it’s so important to not only have a functioning blood glucose meter, but also to understand exactly how it works—and when to seek medical attention. The U.S. Food & Drug Administration (FDA) recently announced that Trividia Health, Inc. is initiating a labeling correction for all True Metrix blood glucose monitoring systems following 114 serious injuries and one death linked to an error code.
It’s important to note that the monitoring systems are not being recalled and remain safe to use. In these meters, an E-5 error code is displayed either due to a test strip error or because blood glucose levels are very high—over 600 mg/dL. According to the announcement, the current instructions fail to emphasize the importance of seeking medical treatment in these instances.
High blood sugar symptoms may include increased thirst, frequent urination, blurred vision, headache, and nausea. Dangerously high levels may lead to serious side effects, and even diabetic ketoacidosis (DKA), a life-threatening condition that requires immediate attention.
Which products are impacted?
This correction affects all True Metrix blood glucose monitoring systems distributed throughout the U.S., the United Kingdom, Mexico, Australia, and the Caribbean. This includes True Metrix, True Metrix Air, True Metrix Go, and True Metrix Pro Blood Glucose Monitoring Systems, as well as the following co-branded products:
- Care One (Ahold)
- CenterWell (Humana)
- CVS
- Discount Drug Mart
- Foster & Thrive/Sunmark/Healthmart (McKesson)
- Good Neighbor Pharmacy (Cencora)
- HEB
- Henry Schein
- HyVee
- Kroger
- Leader (Cardinal Health)
- McKesson (Med Surg)
- Meijer
- ProCure (WynnMed)
- Publix
- Relion (Walmart)
- Rite Aid
- Signature Care (Albertsons)
- Top Care (TopCo)
- Walgreens
- Farmacias Benavides (in Mexico)
The updated instructions related to an E-5 error now read, “WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst, or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip.”
What to do if you have the product?
Simply be aware of the importance of an E-5 Error Code and what it means. Again, it’s important to note that the monitoring systems themselves are not being recalled and remain perfectly safe to use. The only issue at hand here is making sure customers understand how serious an E-5 Error Code is so that anyone who receives that notification on their monitor while experiencing symptoms knows to seek medical attention immediately.
Read the full article here