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 Codes	Image Display Error/Artifact (1304); High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 12-jul-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer.Customer is satisfied with the glucose readings from the new replacement products.
Event or Problem Description
Consumer initially reported complaint for e-3 error.Mother is calling on behalf of the customer.During the call, a blood test was performed by the customer non-fasting and produced test result of hi using true focus meter; the customer was not satisfied with the result obtained.Customer stated he has obtained high blood glucose test results using the true focus meter, the customer¿s expected am fasting blood glucose test result is 180mg/dl.The customer feels well and did not report any symptoms.Customer stated that he speaks with his doctor everyday due to high blood glucose results; doctor had informed customer he is fine and that the true focus meter was not working.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 03/31/2023 and open vial date is (b)(6) 2021.The meter memory was not reviewed for previous test result history; customer stated that the meter displayed 3 zeros (000) and did not display the memory.
Additional Manufacturer Narrative
Sections with additional information as of 31-aug-2021: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were returned for evaluation.Reported defect not reproduced on returned meter and strips.(nova biomedical).Most likely underlying root cause: mlc-018: user has high glucose value.

• 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: 12218054
• Report Number: 1000113657-2021-00448
• Device Sequence Number: 11778886
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/31/2021

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: 03/31/2023
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NY1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Distributor Facility Aware Date: 06/28/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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