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	Insufficient Information (4580)
Date of Event	09/14/2021
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 28- sept-2021 to ensure the replacement products resolved the initial concern- able to establish contact with customer.Customer states replacement products resolved customer¿s initial issue.
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 does not know her expected blood glucose test result range.Customer was not using the proper testing technique.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 blood test was performed by the customer fasting and produced test result of 108mg/dl using true focus meter; customer was satisfied with the result obtained.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 08/24/2023 and test strips were opened one week prior to call.The meter memory was reviewed for previous test result history (only one result): result 1 : lo date: 1/4 time: 2:29am fasting.

• 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: 12605408
• Report Number: 1000113657-2021-00637
• Device Sequence Number: 17265564
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956(
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/11/2021

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: 08/24/2023
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NY1010
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1