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

Model Number	STRIP TMX ECOMMERCE 50CT MG/DL 360/CS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Product testing was performed and defect found on returned test strips: high blood readings.No defect found on returned meter.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Root cause: rc-072: vial left open for an extended period of time.Note: manufacturer contacted customer in a follow-up call on 08-jan-2026 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer called concerned with test results from meter to lab comparison of 142 mg/dl using true metrix meter and lab result of 107 mg/dl performed (b)(6) 2025 am fasting.The customer stated his expected blood glucose test result range is 95-100 mg/dl am fasting.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a blood test was performed by the customer non-fasting and produced test result of 162 mg/dl using true metrix meter.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 12/31/2026 and per the customer the open vial date is few weeks ago.The meter memory was not reviewed for previous test result history.

• 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: 24998633
• Report Number: 1000113657-2026-00178
• Device Sequence Number: 18334201
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)261231(10)ZD6113S
• 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: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP TMX ECOMMERCE 50CT MG/DL 360/CS
• Device Lot Number: ZD6113S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Distributor Facility Aware Date: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown