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	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-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.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Customer's aid is calling on behalf of the customer.The customer is concerned with test results from results obtained of 600, 549, 411, 345 and 327mg/dl.The customer's expected fasting blood glucose test result is 98 mg/dl.The customer feels well and did not report any symptoms.Aide stated when the customer obtained the high results she was not having any diabetic symptoms.Medical attention is not reported as a result of the actual blood glucose results.The customer declined to perform a back to back blood test during the call on (b)(6) 2017.Per customer, the barrel of her lancing device is broken.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 11/24/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1 :600mg/dl date:(b)(6) time:11:20am fasting, result 2 :549mg/dl date:(b)(6) time:12:00pm fasting, result 3 :411mg/dl date:(b)(6) time:10:50am fasting, result 4 :345mg/dl date:(b)(6) time:8:20pm fasting, result 5 :327mg/dl date:(b)(6) time:2:00pm fasting.Customer states results are higher than normal.

• 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: 7121232
• Report Number: 1000113657-2017-02076
• Device Sequence Number: 11102314
• Product Code: NBW
• UDI-Device Identifier: 00010939722447
• UDI-Public: (01)00010939722447
• Combination Product (Y/N): N
• Initial Reporter State: AR
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 11/24/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1