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

Model Number	STRIP, TMX WGN 100CT12/CS MG/DL #383569
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Codes	Fatigue (1849); Polydipsia (2604); Swelling/ Edema (4577)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer had initially reported complaint for error message (e-5).During the call, a back-to-back blood test was performed by the customer am fasting and produced test results of 94 mg/dl and 349 mg/dl using true metrix meter.Customer was concerned that the results were erratic.Customer also stated that he had blood work done for a procedure (not related to diabetes) 30 minutes prior and the result had been 315 mg/dl fasting.The customer does not know his expected blood glucose test result range.The customer reported feeling fatigued; per customer it is an ongoing symptom.Medical attention was not needed at the time of the call.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 05/28/2027 and per the customer the open vial date is(b)(6) 2026.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Test strips were not returned for evaluation - customer had returned the incorrect test strips.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 1: manufacturer contacted customer in a follow-up call on (b)(6) 2026 to ensure the customer's condition had improved - able to establish contact with customer who stated he was still feeling fatigue; customer also stated that he was also feeling thirsty all the time and his feet were swollen.No medical intervention since the last call was reported.Note 2: manufacturer contacted customer in a follow-up call on (b)(6) 2026 to ensure the customer's condition had improved and the replacement products resolved the initial concern - able to establish contact with customer who stated he did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Customer stated replacement products resolved the initial concern.

• 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: 25055656
• Report Number: 1000113657-2026-00184
• Device Sequence Number: 13277490
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270528(10)ZD6282S
• 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 WGN 100CT12/CS MG/DL #383569
• Device Lot Number: ZD6282S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Distributor Facility Aware Date: 04/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2026
• 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