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

Model Number	STRIP, TMX WGN 50CTMG/DL #348014
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Shaking/Tremors (2515)
Date of Event	03/05/2026
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: shaky and weak.Meter was returned - reported defect not reproduced on returned meter.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-062: user had poor technique 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 and erratic blood glucose test results.The customer called concerned with test results from results obtained of 402, 228, 230 and 178 mg/dl.Customer advised that the results from the memory of the meter were taken one right after the other within 2 minutes of each other.The customer does not know their expected blood glucose test result range.The customer reported feeling shaky and weak; medical attention was not needed at the time of the call.During the call, a back-to-back blood test was performed by the customer non-fasting and produced test results of 249 mg/dl and 241 mg/dl using true metrix meter.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 04/30/2027 and per the customer the open vial date is 1 week ago.The meter memory was reviewed for previous test result history: result 1: 402 mg/dl date: (b)(6) 2026 time: am non-fasting.Result 2: 228 mg/dl date: (b)(6) 2026 time: am non-fasting.Result 3: 230 mg/dl date: (b)(6) 2026 time: am non-fasting.Result 4: 178 mg/dl date: (b)(6) 2026 time: am non-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: 24778387
• Report Number: 1000113657-2026-00149
• Device Sequence Number: 12295603
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270430(10)ZD6248S
• 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): 04/02/2026

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 50CTMG/DL #348014
• Device Lot Number: ZD6248S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Distributor Facility Aware Date: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/03/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown