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	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of 494mg/dl.The customer¿s expected pm fasting blood glucose test result range is 200-250mg/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.The customer was not using the proper testing techniques.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 test strip lot manufacturer¿s expiration date is 02/22/2023 and open vial date is one month ago.The meter memory was reviewed for previous test result history (date not set): result 1: 215 mg/dl date: (b)(6) 2021 time: 10:12pm fasting, result 2: 494 mg/dl date: (b)(6) 2021 time: 7:54pm fasting, result 3: 175 mg/dl date: (b)(6) 2021 time: 5:43pm fasting, result 4: 147 mg/dl date: (b)(6) 2021 time: 12:00pm fasting, result 5: 229 mg/dl date: (b)(6) 2021 time: 7:41am fasting.
Additional Manufacturer Narrative
Internal report reference number: (b)(6).Test strips were not returned for evaluation.Meter was returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Additional Manufacturer Narrative
Sections with additional information as of 07-jan-2022 h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: test strips were not returned for evaluation.Meter was returned for evaluation-reported defect not reproduced.No defect found most likely underlying root cause: mlc-062: user had poor technique.

• 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: 13097577
• Report Number: 1000113657-2021-00802
• Device Sequence Number: 19915365
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 02/22/2023
• Device Model Number: STRIP, LEADER TT MEDIMEDI 50CT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5423S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/07/2022
• 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