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	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (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 122, 151 and 147mg/dl.The customer's expected fasting blood glucose test result range is 85 - 110 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 on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 198 mg/dl and 149 mg/dl using truetrack meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 11/25/2018 and open vial date is (b)(6) 2016 (no exact date to verify if strips were expired - four months past date first opened).Customer stated that she has not had any changes to her exercise and diet routine.The meter memory was reviewed for previous test result history (date/time not set): the 122mg/dl (b)(6) 2017 11:32 am fasting:yes, the 151mg/dl (b)(6) 2017 11:28 am fasting:yes, the 147mg/dl (b)(6) 2017 10:46 am fasting:yes, the 134mg/dl (b)(6) 2017 02:38 pm fasting:yes, the 190mg/dl (b)(6) 2017 01:39 am fasting:yes.Memory concerns:customer is concerned with the 122, 151, 147, 134 and 190 mg/dl results from her meter.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip (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 122, 151 and 147 mg/dl.The customer's expected fasting blood glucose test result range is 85 - 110 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 on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 198 mg/dl and 149 mg/dl using truetrack meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 11/25/2018 and open vial date is (b)(6) 2016 (no exact date to verify if strips were expired - four months past date first opened).Customer stated that she has not had any changes to her exercise and diet routine.The meter memory was reviewed for previous test result history (date/time not set): (b)(6).

• 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: 6438840
• Report Number: 1000113657-2017-00567
• Device Sequence Number: 798187
• Product Code: NBW
• UDI-Device Identifier: 00087701405570
• UDI-Public: (01)00087701405570
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/26/2017

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 Expiration Date: 11/25/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/26/2017
• 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