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	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18 user has high glucose value.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for hi.The customer is concerned with the results obtained of hi.The expected fasting blood glucose test result range is 100 to 150mg/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 stored by customer according to specification.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 326 and 388mg/dl using true track meter.The test strip lot manufacturer's expiration date is 01/13/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date / time not set): the 381mg/dl (b)(6) 2017 11:14 am fasting: yes, the 444mg/dl (b)(6) 2017 12:05 pm fasting: yes, the 552mg/dl (b)(6) 2017 09:59 pm fasting: yes, hi (b)(6) 2017 01:31 am fasting: yes, hi (b)(6) 2017 08:31 am fasting: yes.Customer is concerned with the high readings she has obtained recently as she has not had any changes in her daily routine.Customer is also concerned with the hi reading fasting on (b)(6) 2017 at 8:31 am.Customer states time was not set on meter, but the dates are correct.Customer states she was not experiencing any symptoms of high blood sugar when she obtained the hi reading.

• 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: 6677200
• Report Number: 1000113657-2017-01146
• Device Sequence Number: 16154803
• Product Code: NBW
• UDI-Device Identifier: 00021292001261
• UDI-Public: (01)00021292001261
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/29/2017

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: RT4944
• 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: 06/09/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1