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

Model Number	TRUETRACK
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with defect found.Returned test strips evaluated with no defect found.Qc investigation on 2/2/2018 resulted in defect found; returned meter code key damage/dirty.Reported defect not reproduced with returned meter and test strip.Final root cause investigation has been completed: pcb contamination on the code key connector j2 caused by user.Test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained of 423 and 559 mg/dl.The expected fasting blood glucose test result range is 75 to 110 mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 07/13/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly): (b)(6).When attempting to do the back to back testing the meter read code (---) and customer could not test.

• 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: 7267764
• Report Number: 1000113657-2018-00178
• Device Sequence Number: 1917769
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/13/2018

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: RU5075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1