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	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for lo display.The expected fasting blood glucose test result range is undisclosed.Symptoms or medical attention were not reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 02/13/2022 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 26-oct-2020: h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed by contract manufacturer using test strips from the same lot.Retention strip lot tested and passed.Corrected sections as of 26-oct-2020: h10: most likely underlying root cause corrected from "mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test" to "mlc-28: there was not enough information to determine the mlurc".

• 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: 10402274
• Report Number: 1000113657-2020-00572
• Device Sequence Number: 19568992
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: No Information
• Device Expiration Date: 02/12/2022
• Device Model Number: METER, WGN TRUE FOCUSMETER ONLY MG/DL 956968
• Device Lot Number: NW1001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/16/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1