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

Model Number	STRIP, TMX WGN 25CT24/CS MG/DL #383237
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for high blood glucose test results and error messages (e-3 and e-5).The customer is concerned with test results from results obtained on (b)(6) 2024 of 445 and 475 mg/dl (fasting/non-fasting was not disclosed).The customer¿s expected blood glucose test result range was not provided.The customer feels well and did not report any symptoms.Customer stated that due to the high results and error messages she had contacted her doctor on the day of the call.Customer stated that the doctor was out of the office, and she was not given any instructions.During the call, a back-to-back blood test was not performed by the customer.The product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 01/19/2026 and open vial date was not provided.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting doctor due to meter results and error messages.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-020: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call on 31-oct-2024 to ensure the customer's condition had improved - able to establish contact with customer who stated she had gone to the doctor's office on (b)(6) 2024.Customer stated the diagnosis had been high blood glucose and that she had been prescribed insulin due to her blood glucose being so high.Customer reported no diabetic symptoms at the time of the follow-up call.

• 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: 20698015
• Report Number: 1000113657-2024-00450
• Device Sequence Number: 3714531
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)260129(10)ZC5747S
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K143548
• 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): 11/15/2024

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: 01/29/2026
• Device Model Number: STRIP, TMX WGN 25CT24/CS MG/DL #383237
• Device Lot Number: ZC5747S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/25/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/15/2024
• 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