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

Model Number	STRIP, TMX SGC 100CT12/CS MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer called concerned with test results from results obtained of 141, 228, 149 and 218 mg/dl.The customer stated his expected blood glucose test result ranges are 98-125 mg/dl am fasting and below 160 mg/dl 2 hrs.After meals.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 back-to-back blood test was performed by the customer non-fasting and produced test results of 125 mg/dl and 128 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 03/19/2027 and per the customer the open vial date is about month and a half ago the meter memory was reviewed for previous test result history: result 1: 141 mg/dl date: (b)(6) 2026 time: 10:30 am 2 hrs.After meal result 2: 228 mg/dl date: (b)(6) 2026 time: 10:27 am 2 hrs.After meal result 3: 149 mg/dl date: (b)(6) 2026 time: 5:02 am fasting.Result 4: 218 mg/dl date: (b)(6) 2026 time: 5:00 am fasting result 5: 110 mg/dl date: (b)(6) 2026 time: 10:35 2 hrs.After meal.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Test strips were returned - customer had only returned 1 test strip, unable to test.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 a follow-up call on 30-apr-2026 to ensure the replacement products resolved the initial concern - able to establish contact with customer who indicated replacement products resolved initial concern.

• 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: 25191304
• Report Number: 1000113657-2026-00201
• Device Sequence Number: 10702873
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270319(10)ZD6197S
• 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): 05/15/2026

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 SGC 100CT12/CS MG/DL
• Device Lot Number: ZD6197S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Distributor Facility Aware Date: 04/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/15/2026
• 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