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

Model Number	STRIP, LDR TMX 30CT 24/CS MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called for assistance running a blood test.She tried 3 times this morning and the results were high and erratic.The customer was concerned with the tests results obtained of 96, 141 and 113mg/dl.The customer¿s expected am fasting blood glucose test result range is 80-90mg/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.Per customer, the product is not stored according to specification in the bathroom.The test strip lot manufacturer¿s expiration date is 07/29/2027 and per the customer the open vial date is undisclosed.The meter memory was reviewed for previous test result history: result 1: 113 mg/dl date: on (b)(6) time: 8:49am fasting.Result 2: 141 mg/dl date: on (b)(6) time: 8:48am fasting.Result 3: 96 mg/dl date: on (b)(6) time: 8:47am fasting.Result 4: 96 mg/dl date: on (b)(6) time: 5:42pm 2hr after meal.Result 5: 80 mg/dl date: on (b)(6) time: 11:07pm bedtime/unsure.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips and meter were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications most likely underlying root cause: mlc-020: user's test strip had poor storage note: manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

• Brand Name: TRUE METRIX AIR
• 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: 24531659
• Report Number: 1000113657-2026-00095
• Device Sequence Number: 21066275
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270729(10)ZD6343S
• Combination Product (Y/N): N
• PMA/510(K) Number: K150052
• 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): 03/06/2026

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, LDR TMX 30CT 24/CS MG/DL
• Device Lot Number: ZD6343S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/06/2026
• 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
• Patient Sex: Unknown