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

Model Number	STRIP, TRUE METRIX 50CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
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 276 mg/dl.The customer stated her expected am fasting blood glucose test result range is 120-140 mg/dl.Customer stated that she has only been using the meter for less than a month.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 not performed by the customer.Per customer, the product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 06/16/2027 and the open vial date was not provided.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: result 1: 276 mg/dl date: (b)(6) 2026 time: 8:17am fasting am.Result 2: 131 mg/dl date: (b)(6) 2026 time: 8:14pm fasting pm.Result 3: 139 mg/dl date: (b)(6) 2026 time: 8:09pm fasting pm.Result 4: 96 mg/dl date: (b)(6) 2026 time: 12:38pm fasting pm.Result 5: 123 mg/dl date: (b)(6) 2026 time: 7:27am fasting am.
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.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-020: user's test strip had poor storage.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.

• 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: 25241428
• Report Number: 1000113657-2026-00203
• Device Sequence Number: 18775108
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270616(10)ZD6300S
• 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): 05/21/2026

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, TRUE METRIX 50CTMG/DL
• Device Lot Number: ZD6300S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Distributor Facility Aware Date: 04/22/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/21/2026
• 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