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	High Test Results (2457)
Health Effect - Clinical Code	Lethargy (2560)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi; customer had just eaten 1 hour prior to test.The customer does not know their expected blood glucose test result range.At the time of the call the customer was feeling drowsy; medical attention was not needed at the time.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 06/28/2024 and open vial date is (b)(6) 2022.Mother was unable to see the serial number on the meter.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Added most likely underlying root cause onto case as the complaint product was not returned for investigation.Most likely underlying root cause: mlc-018: user has high glucose value.Manufacturer contacted customer in a follow-up call on 14-oct-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated their condition had improved and they did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Customer had disconnected the call and did not provide any further information.

• 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: 15735207
• Report Number: 1000113657-2022-00582
• Device Sequence Number: 17722576
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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: 06/28/2024
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NA1018
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/04/2022
• 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