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	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer is concerned with tests results from results obtained of 126 and 48 mg/dl.The customer's expected fasting blood glucose test result range is 70 to 90 mg/dl.The customer feels well and did not report any symptoms.The product is stored according to specification in the bedroom.Medical attention is not reported as a result of the actual blood glucose results.The test strip lot manufacturer's expiration date is 03/30/2018 and open vial date is (b)(6) 2016.The meter memory was reviewed for previous test result history: (b)(6).Customer called in stating his meter was reading erratic.Customer states he is feeling physically well at time, denies having any symptoms of high or low blood sugar, denies need for medical attention.Customer states his normal range is 70-90 mg/dl fasting, customer is only managing his diabetes with diet and exercise.Customer has not had any recent changes in diet, exercise, or medications.Customer states he is concerned with readings obtained (b)(6) 2016 at 8:40 am of 126 mg/dl and 48 mg/dl.Customer states that he knows the 48 mg/dl is not correct as he was not experiencing any symptoms at time of reading.Customer is storing supplies in bedroom, verified proper technique is being used.Customer is unable to run back to back blood tests at time.

• 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: 6241517
• Report Number: 1000113657-2017-00041
• Device Sequence Number: 13556421
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/11/2017

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/11/2017
• 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