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	06/12/2017
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: mlc-20 user's test strip had poor storage (kitchen).Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 80 to 110mg/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.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 05/30/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date / time not set): the 153mg/dl (b)(6) 2017 12:00 pm fasting: yes, the 331mg/dl (b)(6) 2017 12:46 pm fasting: yes, the 204mg/dl (b)(6) 2017 10:19 am fasting: yes, the 184mg/dl (b)(6) 2017 10:31 am fasting: yes, the 248mg/dl (b)(6) 2017 02:00 pm fasting: yes.The customer called with concerns regarding their meter reading high.The meter's time and date is not set up correctly.
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: mlc-20 user's test strip had poor storage (kitchen).Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 80 to 110mg/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.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 05/30/2019 and open vial date is 5/12/17.The meter memory was reviewed for previous test result history (date / time not set): 153mg/dl (b)(6) 2017 12:00 pm fasting: yes; 331mg/dl (b)(6) 2017 12:46 pm fasting: yes; 204mg/dl (b)(6) 2017 10:19 am fasting: yes; 184mg/dl (b)(6) 2017 10:31 am fasting: yes; 248mg/dl (b)(6) 2017 02:00 pm fasting: yes.The customer called with concerns regarding their meter reading high.The meter's time and date is not set up correctly.

• 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: 6686935
• Report Number: 1000113657-2017-01187
• Device Sequence Number: 129656
• Product Code: NBW
• UDI-Device Identifier: 00010939755339
• UDI-Public: (01)00010939755339
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/03/2017

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: RT5048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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