MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, WGN TMX 30CT 24/CASE MG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Caregiver is calling on behalf of the customer.The customer feels well and did not report any symptoms.Caller advised that on (b)(6) 2026, customer got a result of 44 mg/dl non-fasting, and she took the customer to the er.Customer was not having any symptoms of low blood glucose when they took her to the hospital.Caller advised that before taking the customer to the hospital, she gave her candy.Caller advised that when the customer got to the hospital, the customers blood glucose was in the 50's (non-fasting, unsure of actual result).The diagnosis was low blood glucose.Caller stated that customer was given orange juice and "other things" to try to bring the customers blood glucose levels up.Customer was admitted to the hospital and released 2 days later.Customers diabetic medications were decreased (caller did not specify).Customer was discharged and advised following up with their pcp.During the call, a blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 04/29/2027; product storage and open vial date were not provided.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer seeking medical attention-er meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-134: user has low glucose value note: manufacturer contacted customer in a follow-up call on 12-mar-2026 to ensure the customer¿s initial concern was resolved- the customer is comfortable with the replacement products.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 24620785
• Report Number: 1000113657-2026-00117
• Device Sequence Number: 18698187
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270429(10)ZD6238S
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, WGN TMX 30CT 24/CASE MG/DL
• Device Lot Number: ZD6238S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/18/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown