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

Model Number	STRIP,GOOD NGHBR 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	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 222 and 287 mg/dl; tests were performed back to back and customer did not use the proper back to back testing technique.The customer¿s expected pm fasting blood glucose test result range is 108-125 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 not stored according to specification (bathroom).The test strip lot manufacturer¿s expiration date is 12/22/2022 and open vial date is unknown.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: result 1: 222 mg/dl, date: (b)(6) 2022, time: 2:11 pm fasting.Result 2: 287 mg/dl, date: (b)(6) 2022, time: 2:14 pm fasting.Result 3: 125 mg/dl, date: (b)(6) 2022, time: 2:57 pm fasting.Result 4: 165 mg/dl, date: (b)(6) 2022, time: 2:38 pm fasting.Result 5: 116 mg/dl, date: (b)(6) 2022, time: 2:59 pm fasting.
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 08-jul-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated the initial concern had been resolved and the true track meter is working as intended.
Additional Manufacturer Narrative
Sections with additional information as of 25-aug-2022: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-020: user's test strip had poor storage.

• 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: 15102559
• Report Number: 1000113657-2022-00417
• Device Sequence Number: 12065450
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 12/22/2022
• Device Model Number: STRIP,GOOD NGHBR TT MEDIMEDI 50CT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5414S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/30/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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