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	12/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer called initially for an e-3 error message but when customer obtained a result of 397 mg/dl from blood test done during call, she stated that it was too high compared to the result of 144 mg/dl she received 20 mins ago that was also fasting.The customer's expected fasting blood glucose test result range is 100 - 150 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) 2016, a blood test was performed by the customer fasting and produced test result of 397 mg/dl using truemetrix meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 12/31/2017 and open vial date is (b)(6) 2016.The customer stated she is on insulin.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns: 397 273 200 162mg/dl.
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer called initially for an e-3 error message but when customer obtained a result of 397 mg/dl from blood test done during call, she stated that it was too high compared to the result of 144 mg/dl she received 20 mins ago that was also fasting.The customer's expected fasting blood glucose test result range is 100 - 150 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) 2016, a blood test was performed by the customer fasting and produced test result of 397 mg/dl using truemetrix meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 12/31/2017 and open vial date is (b)(6) 2016.The customer stated she is on insulin.The meter memory was reviewed for previous test result history: 397mg/dl (b)(6) 2016 09:20 am fasting: yes; 144mg/dl (b)(6) 2016 09:24 am fasting: yes; 273mg/dl (b)(6) 2016 05:00 pm fasting: yes; 200mg/dl (b)(6) 2016 09:00 am fasting: yes; 162mg/dl (b)(6) 2016 03:00 pm fasting: yes.Memory concerns: 397 273 200 162mg/dl.

• 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: 6209109
• Report Number: 1000113657-2016-02100
• Device Sequence Number: 444043
• Product Code: NBW
• UDI-Device Identifier: 00021292007614
• UDI-Public: (01)00021292007614
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/16/2017

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: 12/31/2017
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 01/16/2017
• 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