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

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had poor technique.(b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer is concerned with test results from back to back fasting blood tests of 133 and 336 mg/dl.Customer states it has happened before as well on (b)(6) 2017 at 6:59 pm obtaining a reading of 152 mg/dl and 221 mg/dl back to back; customer does not recall if these readings were fasting.Customer is also concerned that readings are high.The customer's expected fasting blood glucose test result range is 85 - 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 fasting and produced test results of 96 mg/dl using truemetrix meter and 114 mg/dl using truemetrix meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 09/30/2017 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: 133mg/dl (b)(6) 2017 12:22 pm fasting:yes, 336mg/dl (b)(6) 2017 12:21 pm fasting:yes, 334mg/dl (b)(6) 2017 12:20 pm fasting:yes, 152mg/dl (b)(6) 2017 06:59 pm fasting:no, 221mg/dl (b)(6) 2017 06:59 pm fasting:no.

• 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: 6560986
• Report Number: 1000113657-2017-00828
• Device Sequence Number: 13476966
• Product Code: NBW
• UDI-Device Identifier: 00052569138526
• UDI-Public: (01)00052569138526
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/11/2017

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: 09/30/2017
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/11/2017
• 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