MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX GO; 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	Pain (1994)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for error message (e-2).The customer reported not feeling well; customer stated that he is having pain inside (exact symptoms not provided) and customer believed his blood glucose was high.During the call, a blood test was performed by the customer fasting and produced test result of 402 mg/dl using true metrix go meter.Customer is aware that his blood glucose is high because his dr.Recently increased his metformin (customer did not advise if this was during a scheduled appointment).The product is stored according to specification; customer stated he had the strips in his truck but just opened them last night.The test strip lot manufacturer¿s expiration date is 07/30/2025.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: pain.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-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 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: 21665796
• Report Number: 1000113657-2025-00095
• Device Sequence Number: 7662478
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)250730(10)ZB5536S
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/21/2025

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: 07/30/2025
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZB5536S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/21/2025
• 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