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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2016
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: strip issue test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results from results obtained of hi.The customer's expected fasting blood glucose test result range is 200 to 400mg/dl.The customer feels well and did not report any symptoms.The product is stored according to specification.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2016, a back to back blood test was performed by the customer non-fasting and produced test results of e-5 and 577mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 11/303/2017 and open vial date is 12/01/2016.The meter memory was reviewed for previous test result history: the 194mg/dl (b)(6) 2016 10:37 pm fasting: yes, the 187mg/dl (b)(6) 2016 05:00 pm fasting: yes, the 540mg/dl (b)(6) 2016 01:53 pm fasting: no, the 597mg/dl (b)(6) 2016 12:58 pm fasting: no, the 126mg/dl (b)(6) 2016 10:19 pm fasting: yes.Customer called in stating he was getting e-5 messages, however customer also mentioned he had received the reading of hi a couple of days ago.Customer states he does not recall if the hi reading was fasting or non-fasting on (b)(6) 2016 at 12:19 pm.Customer has not had any recent changes in his diet, exercise or medications.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6215516
• Report Number: 1000113657-2016-02123
• Device Sequence Number: 976525
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K140100
• 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): 12/30/2016

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1829
• 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: 12/08/2016
• Initial Report FDA Received Date: 12/30/2016
• 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