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

Model Number	STRIP, TMX CVS 25CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
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: 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.The customer is concerned with test results from results obtained of 224, 212, 164 and 275 mg/dl.The customer¿s expected am fasting blood glucose test result range is 97-140 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 back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 07/29/2026 and open vial date is a week ago.The meter memory was reviewed for previous test result history: result 1: 224 mg/dl , date : (b)(6), time: 10:21am fasting, result 2: 212 mg/dl, date: (b)(6), time: 8:32am fasting , result 3: 164 mg/dl, date: (b)(6), time: 11:00am fasting , result 4: 123 mg/dl, date: (b)(6), time: 12:00pm fasting , result 5: 275 mg/dl, date: (b)(6), time: 7:30am fasting.

• 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: 21882975
• Report Number: 1000113657-2025-00141
• Device Sequence Number: 7865374
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)260729(10)ZC5947S
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/22/2025

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 Expiration Date: 07/29/2026
• Device Model Number: STRIP, TMX CVS 25CTMG/DL
• Device Lot Number: ZC5947S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/22/2025
• 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
• Patient Sex: Unknown