{"id":62611,"date":"2026-02-06T19:06:21","date_gmt":"2026-02-06T18:06:21","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/trividia-health-inc-initiates-labeling-correction-for-all-true-metrix-blood-glucose-monitoring-systems\/"},"modified":"2026-02-06T19:06:21","modified_gmt":"2026-02-06T18:06:21","slug":"trividia-health-inc-initiates-labeling-correction-for-all-true-metrix-blood-glucose-monitoring-systems","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/trividia-health-inc-initiates-labeling-correction-for-all-true-metrix-blood-glucose-monitoring-systems\/","title":{"rendered":"Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX\u00ae Blood Glucose Monitoring Systems"},"content":{"rendered":"
\n

FT. LAUDERDALE, Fla.–(BUSINESS WIRE)–Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner\u2019s Booklets\/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems (collectively, the \u201cProducts\u201d) distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean.<\/p>\n

<\/a>
<\/a>
<\/a>
<\/a><\/p>\n

\nTrividia is updating the E-5 Error Code in the \u201cMessages\u201d section of the Owner\u2019s Booklets\/System Instructions for Use<\/b> to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose<\/span>.<\/p>\n

\nThe system displays an E-5 error code for a very high blood glucose event (> 600 mg\/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.<\/p>\n

\nSince August 2014, when TRUE METRIX was launched globally, there have been 114 reported serious injuries, and one (1) death associated with the E-5 Error Code.<\/p>\n

\nUPDATED E-5 INSTRUCTIONS for<\/b> TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO:<\/b><\/p>\n\n\n\n
\n

\nDisplay<\/b><\/p>\n<\/td>\n

\n

\nReason<\/b><\/p>\n<\/td>\n

\n

\nAction<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nE-5<\/b><\/p>\n<\/td>\n

\n

\nVery high blood glucose result (higher than 600 mg\/dL),<\/b><\/p>\n

\nor Test Strip Error<\/p>\n

\n\u00a0<\/p>\n<\/td>\n

\n

\nWARNING!!<\/b><\/p>\n

\nRetest with a new test strip.<\/b><\/p>\n

\nIf the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately.<\/b><\/p>\n

\n\u00a0<\/p>\n

\nIf you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday – Friday, 8AM-8PM EST for assistance.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nUPDATED E-5 INSTRUCTIONS for TRUE METRIX PRO:<\/b><\/p>\n\n\n\n
\n

\nDisplay<\/b><\/p>\n<\/td>\n

\n

\nReason<\/b><\/p>\n<\/td>\n

\n

\nAction<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nE-5<\/b><\/p>\n<\/td>\n

\n

\nVery high blood glucose result (higher than 600 mg\/dL),<\/b><\/p>\n

\nor Test Strip Error<\/p>\n

\n\u00a0<\/p>\n<\/td>\n

\n

\nWARNING!!<\/b><\/p>\n

\nRetest with a new test strip.<\/b><\/p>\n

\nIf the error persists, and the patient has symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately.<\/b><\/p>\n

\nIf the patient has no symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday – Friday, 8AM-8PM EST for assistance.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nIf you have any questions relating to the Owner\u2019s Booklets\/System Instructions for Use update, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or e-mail trividia0126CC@trividiahealth.com<\/a> or visit www.trividiahealth.com\/E-5productnotice<\/a>.<\/p>\n

\nThe correction affects all TRUE METRIX branded Blood Glucose Meters distributed in the United States, United Kingdom, Mexico, Australia and the Caribbean. This includes our co-branded products sold under store or distribution partner names. Please refer to the Product Notice located at www.trividiahealth.com\/E-5productnotice<\/a> for more information on the list of co-brand partners and affected product labeling.<\/p>\n

\nThe company is sending the Product Notice to impacted customers with instructions on what to do, to post the notice where products are stored\/sold, and to forward the notice to device users, if possible. These customers include pharmacies, mail order companies, and distributors where the TRUE METRIX\u00ae<\/sup> meters are sold. Please refer to the Product Notice located at www.trividiahealth.com\/E-5productnotice<\/a> for more information.<\/p>\n

\nYou may continue to use the TRUE METRIX\u00ae <\/sup>Products.<\/b> Products are not to be returned or replaced. This correction does not require removal of the Products from where they are used or sold. This labeling correction impacts the Owner\u2019s Booklets\/System Instructions for Use that accompany the meters at purchase, as well as the online labeling and help guides located on Trividia Health\u2019s website. Trividia Health will notify users of additional mitigation strategies as needed.<\/p>\n

\nTrividia Health has notified the U.S. Food and Drug Administration (FDA) of this action.<\/p>\n

\nAdverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.<\/p>\n

\nComplete and submit the report Online: www.fda.gov\/medwatch\/report.htm<\/a><\/p>\n

\nRegular Mail or Fax: Download form www.fda.gov\/MedWatch\/getforms.htm<\/a> or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.<\/p>\n

\nPatient safety is our top priority, and we apologize for any inconvenience this correction may cause you.<\/p>\n

\nAbout Trividia Health<\/p>\n

\nTrividia Health, Inc., is a global health and wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced performance products for people with diabetes. With products sold under TRUE and store brand labels, the company is the exclusive partner and supplier of affordable, high-quality blood glucose monitoring and health and wellness solutions for the world\u2019s leading retail pharmacies, distributors and mail service providers. For more information, please visit: www.TrividiaHealth.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nAnnmarie Ramos
\n
Media Contact
\n
(800) 342-7226, ext. 3190<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

FT. LAUDERDALE, Fla.–(BUSINESS WIRE)–Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner\u2019s Booklets\/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems (collectively, the \u201cProducts\u201d) distributed in the United States, United Kingdom, Mexico, … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62611","6":"format-standard","7":"category-industry"},"yoast_head":"\nTrividia Health, Inc. 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LAUDERDALE, Fla.–(BUSINESS WIRE)–Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner\u2019s Booklets\/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems (collectively, the \u201cProducts\u201d) distributed in the United States, United Kingdom, Mexico, ... 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