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	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were evaluated: true focus product was received and investigated by nova biomedical.Reported defect not reproduced on returned meter and strips.Most likely underlying root cause: mlc-062: user had poor technique note: manufacturer contacted customer in a follow-up call on 23-feb- 2021 to ensure the replacement products resolved the initial concern.Able to establish contact with customer who stated is comfortable with the results.
Event or Problem Description
Consumer reported complaint for lo display on blood glucose test.The customer is concerned with test results from results obtained of lo mg/dl.The customer¿s expected am fasting blood glucose test result is 140mg/dl and expected before dinner fasting blood glucose test result range is 90-110 mg/dl.Customer was not using the proper testing technique.Customer only used the meter only 3 times the customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The customer declined to perform a blood test during the call.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 12/22/2022 and test strips were opened two days prior to call.The meter memory was reviewed for previous test result history (customer only tested three times): (b)(6).

• 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: 11467114
• Report Number: 1000113657-2021-00173
• Device Sequence Number: 2965702
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 03/11/2021

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: 12/22/2022
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NX1005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Distributor Facility Aware Date: 02/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1