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

Model Number	STRIP, TRUE METRIX 100CTMG/DL
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting paramedics due to meter error message.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-030: user applied blood to strip before inserting strip into meter.Note: manufacturer contacted customer in a follow-up call on 20-apr-2026 to ensure the customer¿s initial concern was resolved- the customer stated he received the replacement but has not used it as if yet.
Event or Problem Description
Consumer reported complaint for error message (e-3).Pharmacist is calling on behalf of the customer.The customer feels well and did not report any symptoms.Customer stated they were getting e-3 and couldn't get a reading, so they ended up calling 911 on the day of the call.When paramedics were there, they opened another bottle of test strips with the same lot number, but they were still getting the e-3 with the new vial.Paramedics were able to test with their own equipment and get a reading (undisclosed reading).During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 11/30/2026; product storage and open vial date were not provided.The meter memory was not reviewed for previous test result history.

• 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: 24947709
• Report Number: 1000113657-2026-00172
• Device Sequence Number: 18605221
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836(17)261130(10)ZD6089S
• Combination Product (Y/N): N
• PMA/510(K) Number: K143548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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, TRUE METRIX 100CTMG/DL
• Device Lot Number: ZD6089S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• 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: Other
• Patient Sex: Unknown