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

Model Number	STRIP, TF WGN 50CTMG/DL 956970
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Returned true focus product will be shipped to nova biomedical for investigations.Most likely underlying root cause: (b)(6): passed open expiration date.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the replacement products resolved the initial concern, customer stated they are comfortable with the replacement products.
Event or Problem Description
Consumer reported complaint for physical defect of test strips.Customer stated that the true focus test strips are brownish in color where the sample should be applied.Customer advised that she is storing them in an unused bathroom and that the strips have been opened for longer than 4 months.The customer feels well and did not report any symptoms.No medical intervention related to the use of the product was reported.Customer was upgraded to true metrix product line.

• Brand Name: TRUE FOCUS
• 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: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 18449171
• Report Number: 1000113657-2024-00002
• Device Sequence Number: 17900724
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131013
• 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): 01/04/2024

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 Expiration Date: 08/31/2024
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NA1019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Distributor Facility Aware Date: 12/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/04/2024
• 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