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

Model Number	STRIP, WGN TMX 60CT 12/CASE MG/DL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: dizzy.Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved - unable to establish contact with customer at this time.
Event or Problem Description
Customer called in to run a blood test.Customer advised that he is feeling dizzy but declined the need for any medical intervention at time.Attempted to train customer to load his lancing device, however, customer was not able to follow along with the directions being given.Customer advised that he will go to the va in the morning (not because of symptoms) for them to visually show him how to open the lancing device.The test strip lot manufacturer¿s expiration date is 06/27/2026; product storage and open vial date were not provided.

• 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: 24019618
• Report Number: 1000113657-2026-00005
• Device Sequence Number: 21130076
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)260627(10)ZC5914S
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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 Expiration Date: 06/27/2026
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Lot Number: ZC5914S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• 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: Other
• Patient Sex: Unknown