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

Model Number	STRIP, CVS TMX 30CT24/CASE MG/DL
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Increased Appetite (4570)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting doctor's office/nurse and pharmacy due to e-5 error message.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Customer returned 1 test strip only, unable to test.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.Note 1: manufacturer contacted customer in a follow-up call on 25-feb-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 her condition had improved and she did not currently have any diabetic symptoms.The customer stated she had gone to her doctor on 02/23/2026 due to a red rash on her leg, she was not sure if it was caused by diabetes.Customer stated the replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for error message (e-5).The customer reported feeling symptoms of hungry and weak; medical attention was not needed at the time of the call.Customer stated that she did call her doctor's that day and talked to the nurse about the e-5 error; per customer she had been advised to speak to the pharmacy or to contact the manufacturer.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 05/31/2027 and per the customer the open vial date is 2 weeks ago.

• 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: 24651733
• Report Number: 1000113657-2026-00130
• Device Sequence Number: 18615737
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270531(10)ZD6290S
• 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): 03/20/2026

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, CVS TMX 30CT24/CASE MG/DL
• Device Lot Number: ZD6290S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Distributor Facility Aware Date: 02/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/20/2026
• 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