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	Hypoglycemia (1912)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Product problem being submitted due to unable to confirm returned test strips were tested by nova biomedical at time of submission.Meter and test strips were returned to nova biomedical.External evaluation completed by nova biomedical and no defect found on returned meter.Nova biomedical tested returned meter with qa test strips, unable to confirm returned test strips were tested by nova biomedical.Most likely underlying root cause: mlc-006: passed expiration date.Note: manufacturer contacted customer in several follow-up calls 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 lo blood glucose test results.The customer is concerned with test results from results obtained of lo.Caller stated the true focus his her meter and that her friend had used it and had obtained the lo result.The expected blood glucose test result range is unknown.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 not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 06/24/2022 and test strips were opened last year (expired).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: (b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 29-sept-2021: h10: confirmed that returned test strips were evaluated by nova biomedical - no defect found on test strips.

• 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: 12421537
• Report Number: 1000113657-2021-00536
• Device Sequence Number: 20056524
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 09/29/2021

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: 06/25/2022
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NX1003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Distributor Facility Aware Date: 08/09/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1