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	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 205, 239 and 217 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 100 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 190 mg/dl and 187 mg/dl using truemetrix meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 05/14/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: the 205mg/dl (b)(6) 2017 01:17 pm fasting: yes, the 239mg/dl (b)(6) 2017 12:33 pm fasting: yes, the 217mg/dl (b)(6) 2017 11:05 am fasting: yes, the 163mg/dl (b)(6) 2017 09:43 pm fasting: yes, the 213mg/dl (b)(6) 2017 08:35 pm fasting: yes.Memory concerns: customer is concerned about all of these readings customer is calling concerning high results.Customer says that she compared results on meter to results on doctor's meter.Customer says his glucose is never above 200mg/dl.Customer performed control test (within range) and back to back blood test.

• 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: 6520038
• Report Number: 1000113657-2017-00733
• Device Sequence Number: 808226
• Product Code: NBW
• UDI-Device Identifier: 00021292007614
• UDI-Public: (01)00021292007614
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/25/2017

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: 05/14/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT2218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/25/2017
• 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