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

Model Number	STRIP, TMX HMN 50CT24/CASE MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting doctor due to meter results.H1: type of reportable event of serious injury being submitted due to no defect being found on the returned products.Meter and test strips were returned for evaluation - product testing was performed and no defect found on returned meter and test strips.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call on 25-mar-2026 - able to establish contact with customer who reported medical intervention since the last call stating he went back to the dr.'s office because the meter was giving high blood results.Customer stated that the dr.Changed the medication- he is taking jardiance.
Event or Problem Description
Consumer reported complaint for high and low blood glucose test results.Customer also called about e-5 labeling correction.Wife is calling on behalf of the customer.The customer stated his expected blood glucose test result range is 60-90 mg/dl fasting.The customer feels well and did not report any symptoms.Caller stated she is concerned the customer's meter is showing high and low results, it will show high results one morning, then low the next.Caller stated they went to a routine appt on (b)(6) 2026 and the doctor changed his medication.The test strip lot manufacturer¿s expiration date is 05/19/2027 and customer stated they did not remember when the test strips were open.Customer stated she will call his doctor to see if they should stop the metformin while he is waiting for the meter.During the call, a back-to-back blood test was not performed by the customer.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: 24807705
• Report Number: 1000113657-2026-00161
• Device Sequence Number: 13431779
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270519(10)ZD6259S
• 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): 04/07/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Device Lot Number: ZD6259S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Distributor Facility Aware Date: 03/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown