MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUETRACK; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, LEADER TT MEDIMEDI 50CT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were returned for evaluation - test strips are expired, unable to test.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Most likely underlying root cause: mlc-012: product expired.Note: manufacturer contacted customer in a follow-up call on 24-mar-2023 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 high blood glucose test results.The customer is concerned with test results from results obtained of 315, 195, 164, 213 and 250 mg/dl.The customer¿s expected am fasting blood glucose test result is <120 mg/dl and expected pm fasting blood glucose test result is <150 mg/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.The product is stored according to specification in the bedroom.The customer's test strips are expired: test strip lot manufacturer¿s expiration date is 02/22/2023 and test strips were opened 8 months prior to the call.The customer did not have another vial of test strips that had been stored and handled correctly.Customer was upgraded to true metrix product line.The meter memory was not reviewed for previous test result history, customer provided results from her logbook: result 1: 315 mg/dl date: (b)(6) am fasting.Result 2: 195 mg/dl unknown date am fasting.Result 3: 164 mg/dl unknown date pm fasting.Result 4: 213 mg/dl unknown date am fasting.Result 5: 250 mg/dl unknown date am fasting.

• Brand Name: TRUETRACK
• 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: 16700341
• Report Number: 1000113657-2023-00191
• Device Sequence Number: 3628762
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• 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): 04/07/2023

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: 02/22/2023
• Device Model Number: STRIP, LEADER TT MEDIMEDI 50CT
• Device Lot Number: RX5423S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Distributor Facility Aware Date: 03/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/07/2023
• 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