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 Code	Dizziness (2194)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for error message (e-2).The customer reported feeling dizzy; customer stated that she had contacted the doctor on the day of the call but had not been able to speak with the doctor.During the call, a blood test was performed by the customer and produced e-2 error message using true metrix meter.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 03/19/2026 and open vial date is (b)(6) 2025.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes (dizziness) and customer contacting doctor due to symptoms.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-014: insufficient blood sample applied to strip (user).Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and the replacement products resolved the initial concern - unable to establish contact with customer at this time.

• 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: 21334679
• Report Number: 1000113657-2025-00043
• Device Sequence Number: 3771881
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)260319(10)ZC5815S
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/07/2025

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 Expiration Date: 03/19/2026
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZC5815S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/07/2025
• 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: Other
• Patient Sex: Unknown