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

Model Number	STRIP, TRUE METRIX 50CTMG/DL
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results and physical defect of test strips.Customer stated that she has 4 vials of the same lot number of test strips and all of them are sticking together.The customer's expected blood glucose test result range was not provided.The customer feels well and did not report any symptoms.Customer stated that she performed a blood test using the true metrix go meter and one of the test strip vials and obtained a result of over 500 mg/dl.Customer stated that she went to the urgent clinic; customer's blood glucose test result at the clinic had been in the 140s (customer did not recall the exact result).Customer had been discharged the same day, (b)(6) 2026.The customer had reported the same complaint in (b)(6) 2025: internal report reference number (b)(4).During the call, a back to back blood test was not performed by the customer.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 08/18/2026 and the open vial date was not provided.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Additional report reference number (b)(4): initial customer call.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-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 contacted customer in a follow-up call on 01-may-2026 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• 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: 25111671
• Report Number: 1000113657-2026-00190
• Device Sequence Number: 21137018
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)260818(10)ZC5969S
• 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: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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 Expiration Date: 08/18/2026
• Device Model Number: STRIP, TRUE METRIX 50CTMG/DL
• Device Lot Number: ZC5969S
• Was Device Available for Evaluation?: No
• 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: 05/07/2026
• 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