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	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 30-dec-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
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.The customer¿s expected am fasting blood glucose test result is 100mg/dl.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; customer had declined stating he had attempted 5 times that morning.The product is stored according to specification in the living 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.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 30-dec-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
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.The customer¿s expected am fasting blood glucose test result is 100mg/dl.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; customer had declined stating he had attempted 5 times that morning.The product is stored according to specification in the living 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.
Additional Manufacturer Narrative
Sections with additional information as of 17-feb-2021: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were returned for evaluation.External evaluation performed by nova biomedical and no defect found.Most likely underlying root cause: mlc-131: extremely low 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13257577
• Report Number: 1000113657-2022-00016
• Device Sequence Number: 5819332
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/17/2022

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
• 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: 01/03/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown