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	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip (b)(4).Note: the test strips referenced in this report are part of recall #1052693-06/13/16-001-r.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 195, 157 and 277 mg/dl.During a routine doctor's visit, the customer shared results with the doctor and doctor stated results were too high based on customer's a1c.The customer's expected fasting blood glucose test result range is 125 - 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 on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 233 mg/dl and 216 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 10/31/2017 and open vial date at time of call is a week; customer's test strips are part of recall.The meter memory was reviewed for previous test result history: the 195mg/dl (b)(6) 2017 09:04 am fasting: yes, the 157mg/dl (b)(6) 2017 09:48 am fasting: yes, the 144mg/dl (b)(6) 2017 08:50 am fasting: yes, the 140mg/dl (b)(6) 2017 08:14 am fasting: yes, the 277mg/dl (b)(6) 2017 12:27 pm fasting: yes.Memory concerns: 195mg/dl.
Additional Manufacturer Narrative
Internal report # (b)(4) returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: the test strips referenced in this report are part of recall #1052693-06/13/16-001-r.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 195, 157 and 277 mg/dl.During a routine doctor's visit, the customer shared results with the doctor and doctor stated results were too high based on customer's a1c.The customer's expected fasting blood glucose test result range is 125 - 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 on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 233 mg/dl and 216 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 10/31/2017 and open vial date at time of call is a week; customer's test strips are part of recall.The meter memory was reviewed for previous test result history: (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: 6880036
• Report Number: 1000113657-2017-01728
• Device Sequence Number: 16524800
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/26/2017

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: 10/31/2017
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1