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

Model Number	STRIP, TMX WGN 25CT24/CS MG/DL #383237
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Additional report reference numbers: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-055: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.Nnote 1: manufacturer contacted customer in a follow-up call on (b)(6) 2025 to ensure the customer's condition had improved - able to establish contact with customer who stated he did not currently have any diabetic symptoms.Customer did state he went to doctor's office yesterday to ask for a temporary meter as he waits for the replacement.Note 2: manufacturer contacted customer in a follow-up call on (b)(6) 2025 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer reported feeling tired; customer stated he had been in the er the night prior.Customer stated his doctor called him yesterday to give him the result of his lab blood work.Doctor had advised him to go to the er as his blood results showed his glucose was over 700 mg/dl.Customer went to the er and they ran his blood sugar and their meter showed it was in the 400's.Customer had taken the true metrix air meter to er and it showed results in the 180's.The diagnosis was high blood glucose and customer was treated with insulin to lower his blood glucose level.Customer stated due to low blood glucose results he had also gone to the er on (b)(6) 2025; no further details were provided.Customer stated he has been in and out of the hospital previously regarding his blood sugar.The customer¿s expected blood glucose test result range and results of concern were not provided.The customer's test strips were expired at the time of the call: manufacturer's expiration date is 09/27/2025; product storage and open vial date were not provided.The meter memory was not reviewed for previous test result history.

• 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: 23393265
• Report Number: 1000113657-2025-00388
• Device Sequence Number: 18636639
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)250927(10)ZC5610S
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/27/2025
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZC5610S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/27/2025
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown