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

Model Number	STRIP, WGN TMX 60CT 12/CASE MG/DL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
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 and control test results.Daughter is calling on behalf of the customer.The customer called concerned with test results from blood glucose test result obtained of 248 mg/dl and control test result of 79 mg/dl.Per caller the customer's expected fasting blood glucose test result range is 125-145 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.Per customer, the product is stored according to specification on the dining room table.The test strip lot manufacturer¿s expiration date is 02/28/2027 and per the caller the open vial date is (b)(6) 2026.The meter memory was reviewed for previous test result history: result 1: 248 mg/dl date:(b)(6) time:4:47p unknown.Result 2: 180 mg/dl date:(b)(6) time:04:26p unknown (daughter's result).Result 3: 79 mg/dl date:(b)(6) time:4:52p control test.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and control solution were returned - reported defect not reproduced on returned meter and control.Test strips were not returned for evaluation.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 23-apr-2026 and 30-apr-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
• 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: 25112100
• Report Number: 1000113657-2026-00193
• Device Sequence Number: 18728819
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270228(10)ZD6173S
• 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): 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 Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Lot Number: ZD6173S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• 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
• 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