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

Model Number	STRIP, TMX GNP 100CTMG/DL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Lethargy (2560)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
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 tested within specifications.Most likely underlying root cause: mlc-073: user not familiar with system ifu.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2026 to ensure that customer's condition had improved - able to establish contact with customer who reported he had been hospitalized on (b)(6) 2026 for possible stroke; customer could not confirm if the hospitalization was due to diabetes or if it was actually a stroke.Per customer, at the hospital he had mri, mra, ct scan all of the brain and numerous tests were performed.Customer does not recall his blood glucose when at the hospital.No new medications were given.Customer advised that he was referred to a neurologist and to follow up with his pcp.
Event or Problem Description
Customer called in to get some information on the use of the meter and ranges for testing as he is a newly diagnosed diabetic.Customer advised that he is feeling sluggish but declined the need for any medical intervention at this time and was able to proceed with the call.Customer was advised of provided ranges for non-diabetics as noted in the thi ifu manual and also with information regarding clinically low/high results.Customer satisfied with the explanation given and is not concerned with the reading 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: 24746931
• Report Number: 1000113657-2026-00144
• Device Sequence Number: 21018735
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)270331(10)ZD6213S
• 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): 03/31/2026

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 Model Number: STRIP, TMX GNP 100CTMG/DL
• Device Lot Number: ZD6213S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown