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	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product does not return for evaluation yet.Most likely underlying root cause of malfunction:user had an inaccurate reference.(b)(4).
Event or Problem Description
Costumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 210, 242, 214 and 315mg/dl.The customer's expected fasting blood glucose test result range is 149 to 189mg/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 298 and 316mg/dl.The test strip lot manufacturer's expiration date is 12/25/2017 and open vial date is approximately five days ago.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
(b)(4).Investigation completed and product system evaluated with no defect found.Most likely underlying root cause of malfunction:user had an inaccurate reference.(b)(4).
Event or Problem Description
Costumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 210, 242, 214 and 315mg/dl.The customer's expected fasting blood glucose test result range is 149 to 189mg/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 298 and 316mg/dl.The test strip lot manufacturer's expiration date is 12/25/2017 and open vial date is approximately five days ago.The meter memory was reviewed for previous test result history: (b)(6).Memory concern:high results.

• 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: 6159609
• Report Number: 1000113657-2016-01996
• Device Sequence Number: 19015367
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/15/2016

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: MT1856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 12/15/2016
• 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