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

Model Number	STRIP, TMX PBX 100CT12/CASE MG/DL
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
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 replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for erratic and low blood glucose test results.The customer called concerned with test results from results obtained of 65, 68, 64, 61 and 97 mg/dl.The customer stated her expected blood glucose test result ranges are below 100 mg/dl am fasting and below 180 mg/dl 2 hrs.Post meal.The customer feels well and did not report any symptoms.Customer advised that on (b)(6) 2026 when she was getting the low results (no symptoms), she had called her doctor to ask what she should do.Per customer her doctor advised her that if she is not having symptoms to go with the higher of the result and if she is having symptoms to go with the lower result.During the call, a back-to-back blood test was performed by the customer pm fasting and produced test results of 62 mg/dl and 65 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 06/30/2027 and per the customer the open vial date is 1 week ago.The meter memory was reviewed for previous test result history: result 1: 65 mg/dl date: (b)(6) 2026 time: 2:24 pm unsure.Result 2: 68 mg/dl date: (b)(6) /2026 time: 9:53 pm unsure.Result 3: 64 mg/dl date: (b)(6) 2026 time: 9:52 pm unsure.Result 4: 61 mg/dl date: (b)(6) 2026 time: 9:49 pm unsure.Result 5: 97 mg/dl date: (b)(6) 2026 time: 9:41 pm unsure.

• 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: 25116381
• Report Number: 1000113657-2026-00196
• Device Sequence Number: 10346908
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270630(10)ZD6317S
• 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): 05/07/2026

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 PBX 100CT12/CASE MG/DL
• Device Lot Number: ZD6317S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• 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