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

Model Number	STRIP, TMX WGN 25CT24/CS MG/DL #383237
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Dysgeusia (4424)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for error messages (e-2 and e-3).Spouse is calling on behalf of the customer.At the time of the call the customer feels well and did not report any symptoms.Per caller, ems had been called on 01/08/2026 due to customer experiencing symptoms of high blood glucose: caller stated the customer had been feeling dizzy and had a weird taste in his mouth.Caller stated that the customer did not have the true metrix meter with him; per caller the customer had not been testing for some time.Caller stated the customer had been taken to the er and was diagnosed with high blood glucose and given medication.The customer was discharged from the hospital on (b)(6) 2026; customer was given prescriptions, advised to start monitoring his blood sugar and to follow-up with his primary care physician.Per caller, the product is not stored according to specification and is being stored in the car.The test strip lot manufacturer¿s expiration date is 03/31/2024 (expired).The customer did have another vial of test strips that had been stored and handled correctly: lot number zd6004s, manufacturer¿s expiration date is 08/31/2026 and open vial date is 01/14/2026.During the call, a blood test was performed by the customer and produced e-2 error message using true metrix meter.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips (2 vials) were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 06-feb-2026 to ensure the replacement products resolved the initial concern - able to establish contact with customer's caregiver who stated the customer had not yet started using the replacement product; per caregiver, the customer had received a cgm and will be using the true metrix as a backup.

• 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: 24297357
• Report Number: 1000113657-2026-00045
• Device Sequence Number: 15809156
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)240331(10)ZA4924S
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 02/09/2026

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: 03/31/2024
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZA4924S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/09/2026
• 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; Other
• Patient Sex: Unknown