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

Model Number	KIT, WALGREENS TMX METERMG/DL #348013
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned- defect found on returned meter - unknown error: e-7.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Root cause: rc-001: miscellaneous user induced contamination on the strip connector.Note: manufacturer contacted customer in a follow-up call on 24-feb-2026 to ensure the customer¿s initial concern was resolved- the customer is comfortable with the replacement products.
Event or Problem Description
Consumer believes meter has been used (possible tampering) due to results in meter memory that do not belong to the customer.The customer stated he hasn't used the meter- he just received it yesterday at walgreens.When trying to pair notice the meter he noticed it already contained results.Customer stated the box came sealed (like it came from the factory) and everything was sealed in the box.Customer was advised to discontinue use of the meter.The customer feels well and did not report any symptoms.Medical attention is not reported as a result.The test strip lot manufacturer¿s expiration date is 07/29/2027 and per the customer the open vial date is undisclosed.The meter memory was reviewed for previous test result history: customer provided the result of: result: 94mg/dl date: (b)(6) time: 8p.Result: 224mg/dl date: (b)(6) time: 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: 24533131
• Report Number: 1000113657-2026-00098
• Device Sequence Number: 10337769
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270729(10)ZD6344S
• 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): 03/06/2026

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: KIT, WALGREENS TMX METERMG/DL #348013
• Device Lot Number: ZD6344S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Distributor Facility Aware Date: 02/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/06/2026
• 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