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

Model Number	STRIP, PBX 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	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and 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 initial concern is resolved - 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 154, 171, 163 and 256 mg/dl.The customer stated his expected am fasting blood glucose test result range is 120-150 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 performed by the customer non-fasting and produced test results of 180 mg/dl and 180 mg/dl using true metrix air meter.Per customer, the product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 01/30/2027 and per the customer the open vial date is 3 weeks ago.The meter memory was reviewed for previous test result history: result 1: 125 mg/dl date: (b)(6) 2026, time: 5:17 am fasting, result 2: 154 mg/dl date: (b)(6) 2026, time: 4:30 am fasting, result 3: 171 mg/dl date: (b)(6) 2026, time: 5:10 am fasting, result 4: 163 mg/dl date: (b)(6) 2026, time: 4:38 am fasting, result 5: 256 mg/dl date: (b)(6) 2026, time: 4:37 am fasting.

• 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: 24308826
• Report Number: 1000113657-2026-00048
• Device Sequence Number: 15872861
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270130(10)ZD6137S
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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, PBX TMX 30CT 24/CS MG/DL
• Device Lot Number: ZD6137S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/10/2026
• 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