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

Model Number	STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Diaphoresis (2452)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
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: (b)(4): 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 30-mar-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.Customer also called regarding e-5 correction letter she received.The customer feels well and did not report any symptoms.Customer advised that on (b)(6) 2026 when she tested in the morning, her blood glucose was 304 mg/dl fasting; she stated that she was sweating and feeling dizzy, so she called 911 and was taken to the hospital.Customer could not advise what her blood glucose level was when she went to the hospital.Customer was not admitted but discharged the same morning with a blood glucose of 173 mg/dl (undisclosed fasting/non-fasting and advised to follow-up with her pcp.The customer's expected blood glucose test result range was not provided.During the call, a blood test was performed by the customer non-fasting and produced test result of 241 mg/dl using true metrix meter.The test strip lot manufacturer¿s expiration date is 06/30/2027; product storage and open vial date were not provided.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUE METRIX
• 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: 24767151
• Report Number: 1000113657-2026-00153
• Device Sequence Number: 9153137
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270630(10)ZD6320S
• 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): 04/02/2026

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 Model Number: STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL
• Device Lot Number: ZD6320S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/02/2026
• 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: Hospitalization; Other
• Patient Sex: Unknown