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

Model Number	STRIP, CVS TMX 30CT24/CASE MG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4) test strips and meter were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-057: user had an inaccurate reference: alternate meter: the end user is comparing results obtained from one of trividia¿s bgm system to the results from another trividia¿s bgm system manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer called with concerned with the tests results obtained of 74, 73 and 52mg/dl.The customer¿s expected blood glucose test result range is 94mg/dl non fasting am and 116mg/dl after pm medication.Customer states that the meter is not matching up the old meter (comparison results not provided).The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.Per customer, the product is not stored according to specification in the kitchen.The test strip lot manufacturer¿s expiration date is 10/15/2026 and per the customer the open vial date is two days ago.The meter memory was reviewed for previous test result history: result 1: 74 mg/dl date: (b)(6) 2026 time: 626am non-fasting am, (took meds before testing) result 2: 52 mg/dl date: (b)(6) 2026 time: 523pm non-fasting, (no symptoms) result 3: 73 mg/dl date: (b)(6) 2026 time: 803am non-fasting, result 4: 128 mg/dl date: (b)(6) 2026 time: 915pm non-fasting.Result 5: n/a.
Additional Manufacturer Narrative
Sections with additional information as of 14-apr-2026: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Most likely underlying root cause: mlc-057: user had an inaccurate reference: alternate meter: the end user is comparing results obtained from one of trividia¿s bgm system to the results from another trividia¿s bgm system.

• 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: 24531402
• Report Number: 1000113657-2026-00094
• Device Sequence Number: 10343704
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)261015(10)ZD6036S
• 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,Followup
• Report Date (Section B): 04/14/2026

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, CVS TMX 30CT24/CASE MG/DL
• Device Lot Number: ZD6036S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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