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	High Test Results (2457)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: anxiety.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-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.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.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer called concerned with test results from results obtained of 208, 180, 221 and 195 mg/dl.The customer does not know her expected blood glucose test result range.The customer reported feeling anxious and felt it may have been associated to her diabetes; medical attention was not needed at the time of the call.During the call, a back-to-back blood test was not performed by the customer.Per customer, the product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 03/26/2027 and per the customer the open vial date is 1 week.The meter memory was reviewed for previous test result history (customer was unable to see time/date): result 1: 208 mg/dl date: (b)(6) fasting, result 2: 180 mg/dl date: (b)(6) fasting, result 3: 221 mg/dl date: (b)(6) fasting, result 4: 195 mg/dl unknown.

• 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: 24788718
• Report Number: 1000113657-2026-00160
• Device Sequence Number: 9845235
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)270326(10)ZD6208S
• 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: 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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZD6208S
• Was Device Available for Evaluation?: No
• 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): 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