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	06/23/2017
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: (b)(4) user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with the result of 578mg/dl.The expected fasting blood glucose test result range is 200 to 225mg/dl.The customer did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6)2017, a back to back blood test was performed fasting or non-fasting) by the customer and produced test results of 205 and 215mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 06/30/2018 and open vial date is (b)(6)2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly) a 274mg/dl (b)(6)2017 05:03 pm fasting: yes.A 382mg/dl (b)(6)2017 09:48 am fasting: yes.A 303mg/dl (b)(6)2017 06:49 pm fasting: yes.A 249mg/dl (b)(6)2017 05:06 pm fasting: yes.A 578mg/dl (b)(6)2017 03:08 pm fasting: yes.Customer complained of higher 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: 6719359
• Report Number: 1000113657-2017-01429
• Device Sequence Number: 1736479
• 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
• Report Date (Section B): 07/17/2017

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1