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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Wife is calling on behalf of the customer.The customer called concerned with test results from results obtained of 464, 293, 257, 462 and 269 mg/dl.The customer stated his expected blood glucose test result is under 140 mg/dl fasting am.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a blood test was performed by the customer non-fasting and produced test result of 486 mg/dl using true metrix meter.Per customer, the product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 10/31/2026 and per the customer the open vial date is 1 month ago.The meter memory was reviewed for previous test result history: result 1: 464 mg/dl date: (b)(6) 2026 time:608am fasting am, result 2: 293 mg/dl date: (b)(6) 2026 time:557am fasting am , result 3: 257 mg/dl date: (b)(6) 2026 time: 524am fasting am, result 4: 462 mg/dl date: (b)(6) 2026 time: 340am fasting am , result 5: 269 mg/dl date: (b)(6) 2026 time: 556am fasting am.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned - reported defect not reproduced on returned meter.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-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 made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

• 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: 24815056
• Report Number: 1000113657-2026-00164
• Device Sequence Number: 9686475
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)261031(10)ZD6056S
• 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): 04/08/2026

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, TRUE METRIX NFRS24/CS 50CT MG/DL
• Device Lot Number: ZD6056S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Distributor Facility Aware Date: 03/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/08/2026
• 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
• Patient Sex: Unknown