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

Model Number	STRIP, WGN TMX 30CT 24/CASE MG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Product testing was performed and no defect found on returned meter and test strip.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in a follow-up call on 17-mar-2026 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for low blood glucose test results and error message (e-3).Wife is calling on behalf of the customer.The customer called concerned with test results from meter-to-meter comparison of 169 mg/dl using true metrix meter and 210 mg/dl using another device (fasting/non-fasting not provided).Caller stated the customer's expected fasting blood glucose test result is 110 mg/dl.The customer feels well and did not report any symptoms.Caller stated she thought customer was having a stroke, so she had taken him to the hospital on 03/05.Per caller when the doctor saw him, the customer's glucose was high; the hospital's meter showed 210 mg/dl while the true metrix meter showed 169 mg/dl.Per caller, the customer is still in the hospital being monitored.During the call, a back-to-back blood test was not performed by the customer.Per caller, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 06/30/2027 and per the caller the open vial date is 1 week ago.The meter memory was not reviewed for previous test result history.

• 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: 24788622
• Report Number: 1000113657-2026-00159
• Device Sequence Number: 18333930
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270630(10)ZD6317S
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, WGN TMX 30CT 24/CASE MG/DL
• Device Lot Number: ZD6317S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Distributor Facility Aware Date: 03/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown