MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 397 and 361mg/dl.The customer's expected fasting blood glucose test result range is 90 to 115mg/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 on (b)(6) 2016, a back to back blood test was performed by the customer fasting and produced test results of 114 and 135mg/dl using true track meter.The test strip lot manufacturer's expiration date is 09/30/2018 and open vial date is (b)(6) 2016.The meter memory was reviewed for previous test result history (date / time not set): a 112mg/dl, (b)(6) 2016 12:00 am, fasting: yes.A 397mg/dl, (b)(6) 2016 12:00 am, fasting: yes.A 361mg/dl, (b)(6) 2016 12:00 am, fasting: yes.A 178mg/dl, (b)(6) 2016 12:00 am, fasting: yes.A 166mg/dl, (b)(6) 2016 12:00 am, fasting: yes.Dates and times are subjective to the customer's records.Customer has issues with her vision.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 397 and 361mg/dl.The customer's expected fasting blood glucose test result range is 90 to 115mg/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 on (b)(6) 2016, a back to back blood test was performed by the customer fasting and produced test results of 114 and 135mg/dl using true track meter.The test strip lot manufacturer's expiration date is 09/30/2018 and open vial date is 12/05/2016.The meter memory was reviewed for previous test result history (date / time not set): the 112mg/dl (b)(6) 2016 12:00 am fasting: yes, the 397mg/dl (b)(6) 2016 12:00 am fasting: yes, the 361mg/dl (b)(6) 2016 12:00 am fasting: yes, the 178mg/dl (b)(6) 2016 12:00 am fasting: yes, the 166mg/dl (b)(6) 2016 12:00 am fasting: yes.Dates and times are subjective to the customer's records.Customer has issues with her vision.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6228986
• Report Number: 1000113657-2017-00024
• Device Sequence Number: 937751
• Product Code: NBW
• UDI-Device Identifier: 00021292001797
• UDI-Public: (01)00021292001797
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/08/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY