MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Weakness (2145); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-18 extremely high glucose (b)(4).Note: after several attempts manufacturer contacted customer on (b)(4) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.She states that she went to the hospital on (b)(6) 2017 and was hospitalized due to hyperglycemia until (b)(6) 2017.She was treated with insulin and metformin.At the time of the call she was feeling weak and woozy.She got a blood glucose of 169 mg/dl in the morning.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.The customer is concerned with tests results obtained of e-5 and symptoms.The customer's expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of frequent urination and excessive thirst.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is storage location is undisclosed.The test strip lot manufacturer's expiration date is 06/30/2018 and open vial date is about one week ago.The meter memory was not reviewed for previous test result history.E-5 occurs after the blood is applied to the strip (non- fasting).Customer is complaining of frequent urination and excessive thirst.

• 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: 6597858
• Report Number: 1000113657-2017-00915
• Device Sequence Number: 19029641
• 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): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2312
• 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: 05/04/2017
• Initial Report FDA Received Date: 05/30/2017
• 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