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

Model Number	STRIP, WGN TMX 60CT 12/CASE MG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Sepsis (2067); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	10/16/2025
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 returned (customer had also returned control solution).Product testing was performed and no defect found on returned meter and test strips.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.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.
Event or Problem Description
Rescue squad reported complaint for hi and high blood glucose test results.Caller also reported complaint for control test result out of control range.Per the caller, the true metrix go meter had been used to test a patient and a result of 434 mg/dl had been obtained (undisclosed if fasting or non-fasting); the patient had been retested a minute later and the meter read hi (verified in the meter memory).The patient had not been experiencing any symptoms at the time; the patient has a mental illness, and their blood glucose had been tested as per procedure.Due to the high and hi results the patient had been taken to the er on (b)(6) 2025.The patient¿s blood glucose lab result when at the er had been 127 mg/dl (undisclosed if fasting or non-fasting).Caller was unable to provide any additional information as to what transpired after the rescue squad had left the hospital but did state that the patient had been treated for sepsis.The test strip lot manufacturer¿s expiration date is 4/30/2026 and per the caller the open vial date is less than 30 days.The caller stated he is not sure which of the 3 test strip lot numbers had been used when the high and hi results had been obtained, and also when the control test had been performed with result out of range.

• Brand Name: TRUE METRIX GO
• 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: 23733087
• Report Number: 1000113657-2025-00447
• Device Sequence Number: 13410235
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)260430(10)ZC5858S
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K143548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Lot Number: ZC5858S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown