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

Model Number	STRIP, TMX MJR 30CT12/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	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number:(b)(4).Meter was returned - reported defect not reproduced on returned meter.Test strips were not returned - customer had returned the incorrect test strips.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.Wife is calling on behalf of the customer.The customer called concerned with test results from results obtained of 212, 315, 245, 243, and 366 mg/dl.Caller stated the customer's expected blood glucose test result range is fasting 80-97 mg/dl am, and evening - 1 hr.After eating - pm 196-216 mg/dl.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 not performed by the customer.Per caller, the product is stored according to specification in the closet.The test strip lot manufacturer¿s expiration date is 02/28/2027 and per the caller the open vial date is 1 week.The meter memory was reviewed for previous test result history: result 1: 212 mg/dl date: (b)(6) time: 9:46am fasting , result 2: 315 mg/dl date: (b)(6) time: 11:05pm non-fasting , result 3: 245 mg/dl date: (b)(6) time: 9:53am fasting , result 4: 243 mg/dl date: (b)(6) time: 9:57am fasting, result 5: 366 mg/dl date: (b)(6) time: 10:48pm non-fasting, result 6: 54 mg/dl date: (b)(6) time: 9:47am fasting (customer was not concerned with the results of 54 mg/dl).

• Brand Name: TRUE METRIX GO
• 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: 25125388
• Report Number: 1000113657-2026-00198
• Device Sequence Number: 8661336
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270228(10)ZD6177S
• Combination Product (Y/N): N
• PMA/510(K) Number: K143548
• 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): 05/08/2026

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, TMX MJR 30CT12/CASE MG/DL
• Device Lot Number: ZD6177S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Distributor Facility Aware Date: 04/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/08/2026
• 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