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

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.(b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Sister is calling on behalf of the customer.The customer is concerned with all tests results from the meter memory.The customer's expected fasting blood glucose test result range is 135 - 175 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 140 mg/dl and 159 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 09/28/2018 and open vial date at time of call is two months.The meter memory was reviewed for previous test result history: 77mg/dl, (b)(6) 2017, 09:39 pm, fasting: yes; 73mg/dl, (b)(6) 2017, 09:30 pm, fasting: yes; 30mg/dl, (b)(6) 2017, 09:12 pm, fasting: yes; 81mg/dl, (b)(6) 2017, 10:30 am, fasting: yes; 68mg/dl, (b)(6) 2017, 10:24 am, fasting: yes.Memory concerns: customer is concern with all these results.(b)(6) (sister) calling states that the meter is not giving correct results.

• 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: 6807009
• Report Number: 1000113657-2017-01589
• Device Sequence Number: 10797289
• Product Code: NBW
• UDI-Device Identifier: 00021292009281
• UDI-Public: (01)00021292009281
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

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: 09/28/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1