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

Model Number	STRIP, WGN TMX 30CT 24/CASE MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Dry Mouth (4485)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2026 to ensure that the customer's condition had improved - able to establish contact with customer who stated she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer's expected blood glucose test result range was not provided.Customer has dry mouth but declined the need for any medical intervention at this time.Customer advised that she has not taken her oral medications or her insulin all day.During the call, a blood test was performed by the customer and produced test results of hi using true metrix go meter.Customer advised that she is not concerned with the hi as she has not taken any meds today.The test strip lot manufacturer¿s expiration date is 07/31/2027; product storage and open vial date were not provided.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUE METRIX GO
• 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: 24947734
• Report Number: 1000113657-2026-00173
• Device Sequence Number: 21339600
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270731(10)ZD6349S
• Combination Product (Y/N): N
• PMA/510(K) Number: K143548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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, WGN TMX 30CT 24/CASE MG/DL
• Device Lot Number: ZD6349S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• 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
• Patient Sex: Unknown