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

Model Number	STRIP, TMX KGR 100CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned: reported defect not reproduced on returned meter.Retention testing was performed using test strips from the same lot.Retention strips 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 a follow-up call on 22-dec-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer called concerned with test results from results obtained of 214, 203, 248 and 227 mg/dl.The customer stated her expected am fasting blood glucose test result range is 104-115 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 in the bedroom.The test strip lot manufacturer¿s expiration date is 04/29/2027 and per the customer the open vial date is 1 month.The meter memory was reviewed for previous test result history: result 1: 214 mg/dl, date: on (b)(6), time: 2:51am fasting.Result 2: 203 mg/dl, date: on (b)(6), time: 5:09pm unknown.Result 3: 248 mg/dl, date: on (b)(6), time: 10:45am fasting.Result 4: 227 mg/dl, date: on (b)(6), time: 10:43am fasting.Result 5: 107 mg/dl, date: on (b)(6), time: 9:37am fasting.

• 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: 25055932
• Report Number: 1000113657-2026-00185
• Device Sequence Number: 21365336
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270429(10)ZD6235S
• 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): 05/01/2026

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, TMX KGR 100CTMG/DL
• Device Lot Number: ZD6235S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Distributor Facility Aware Date: 04/03/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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