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

Model Number	METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Meter and test strips were not returned for evaluation.Adverse event report is being submitted due to symptoms related to diabetes: dizziness.Manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved -and to ensure the replacement products resolved the initial concern- unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for hi and high blood glucose test results.Niece is calling on behalf of the customer.Customer had purchased the true focus meter the day prior to call.The customer is concerned with test results from results obtained of hi and 600 mg/dl.The customer did not know his expected blood glucose test result range.At the time of the call, the customer reported feeling dizzy and that he may seek medical attention.During the call, a blood test was performed by the customer and produced test result of hi using true focus meter.The product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 12/22/2022 and open vial date is undisclosed.The meter memory was reviewed for previous test.Result history: (customer unable to read time and date).Result 1: hi date: 2/19 time: 1:00 am.Result 2: 600 mg/dl date/time: unknown non-fasting.Result 3: n/a.Result 4: n/a.Result 5: n/a.

• 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
• MDR Report Key: 11517125
• Report Number: 1000113657-2021-00181
• Device Sequence Number: 3430425
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 12/22/2022
• Device Model Number: METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
• Device Lot Number: NX1005
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other