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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for lo blood glucose test results.The customer is concerned with test results from results obtained of lo; customer was also concerned with results obtained of 182 and 131 mg/dl.The customer does not know their expected blood glucose test result range.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back-to-back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The customer's test strips are expired: customer stated he does not test his blood very frequently and never realized his strips were expired.The test strip lot manufacturer¿s expiration date is 12/23/2022 and open vial date was not provided.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: result 1: lo date: on (b)(6) time: 5:33am fasting, result 2: lo date: on (b)(6) time: 8:35am fasting, result 3: 182 mg/dl date: on (b)(6) time: 8:33am fasting, result 4: lo date: on (b)(6) time: 9:28am fasting, result 5: 131 mg/dl date: on (b)(6) time: 10:27am fasting.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips (expired) were not returned for evaluation.Most likely underlying root cause: mlc-012: product expired.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• 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: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 20346742
• Report Number: 1000113657-2024-00394
• Device Sequence Number: 7805179
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956(17)221223(10)NX1006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/01/2024

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: 12/23/2022
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NX1006
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/01/2024
• 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
• Patient Sex: Unknown