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

Model Number	STRIP, TMX WGN 25CT24/CS MG/DL #383237
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Dyspnea (1816); Hyperglycemia (1905); Confusion/ Disorientation (2553); Hallucination (4428)
Date of Event	08/26/2025
Type of Reportable Event	Death
Event or Problem Description
Consumer reported complaint for error message (e-5).Sister is calling on behalf of the customer.During the call, a blood test was performed by the customer and produced e-5 error message using true metrix meter.Customer was experiencing hallucinations and confusion.Caller asked if she should give customer insulin and was advised that manufacturer is unable to advise as to medication.Caller then stated that she is going to call the paramedics.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 01/29/2027 and open vial date is 08/26/2025.
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 passed within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.Note: customer contacted manufacturer on 28-aug-2025.Caller stated that the customer had passed away on (b)(6) 2025.After the initial call on (b)(6) 2025 customers sister had called the ambulance.When they came, caller advised that they took the customer out of the home and were ¿working on him for over an hour.¿ caller advised that when the paramedics arrived, his breathing was labored.Customer was taken to the hospital where he passed.Customer had been diagnosed with elevated blood glucose levels; caller advised that customers blood glucose was over 1000 mg/dl.Caller advised that customer neglected his diabetes and was not taking care of himself.Caller also advised that this was the third time in one month in which the ambulance was called due to the customers diabetic issues.

• 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: 23099374
• Report Number: 1000113657-2025-00323
• Device Sequence Number: 8765398
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)270129(10)ZD6135S
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZD6135S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/19/2025
• 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
• Outcome Attributed to Adverse Event: Death; Other; Hospitalization
• Patient Sex: Unknown