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	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer called concerned with test results from results obtained of hi.The customer does not know his expected blood glucose test result range.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 blood test was performed by the customer fasting and produced test result of hi using true metrix air meter.Per customer, the product is stored outside of the kitchen.The test strip lot manufacturer¿s expiration date is 07/15/2027 and per the customer the open vial date is 04/2026.The meter memory was reviewed for previous test result history: result 1: hi mg/dl date: 4/13 time: 5:39pm fasting.Result 2: hi mg/dl date: 4/13 time: 5:09pm fasting.Result 3: 425 mg/dl date: 4/13 time: 1:49pm non-fasting.Result 4: 335 mg/dl date: 4/13 time: 11:44am fasting.Result 5: 408 mg/dl date: 4/13 time: 11:25am fasting.
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-020: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call on 27-apr-2026 to ensure that the initial concern was resolved - able to establish contact with customer who stated is comfortable with the glucose readings from the product.

• 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: 25116064
• Report Number: 1000113657-2026-00195
• Device Sequence Number: 9326573
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270715(10)ZD6327S
• 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: Other
• 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, TRUE METRIX 50CTMG/DL
• Device Lot Number: ZD6327S
• 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