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 Code Available (3191)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 210, 244 and 175 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 140 mg/dl.During the call on (b)(6) 2017, the customer felt well and did not report any symptoms.The customer stated he obtained a reading on (b)(6) 2017 at 5:59 am of 175 mg/dl fasting while he was experiencing symptoms of low blood sugar; lightheaded.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 01/31/2018 and open vial date at time of call is two weeks.The customer stated has not had any recent changes in his daily routine and manages his diabetes with diet and exercise.The customer stated he is not concerned with the 268 mg/dl reading as it was non-fasting.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns:199mg/dl, 210mg/dl, 244mg/dl, 175mg/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: 6347485
• Report Number: 1000113657-2017-00354
• Device Sequence Number: 603650
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/21/2017

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: 01/31/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1912
• 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: 01/27/2017
• Initial Report FDA Received Date: 02/21/2017
• 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