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

Model Number STRIP, TF WGN 50CTMG/DL 956970

Device Problem High Test Results (2457)

Patient Problem Lethargy (2560)

Event Date 10/11/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 307627261
• Report Number: 1000113657-2022-00582
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1