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 Code	Headache (1880)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-78- user hematocrit low.(b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition has improved and she denies having any diabetic symptoms.Customer called paramedics to check her sugar and received a reading of 170mg/dl fasting.No treatment was provided.
Event or Problem Description
Consumer reported complaint for e-0 blood glucose results accompanied by symptoms.Niece is calling on behalf of the customer.The customer is concerned with results obtained of e-0.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of having a headache.Customer states she has a headache, does not know if it is related to diabetes.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of e-0 using true metrix meter.The test strip lot manufacturer's expiration date is 02/28/2019 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.Caller states she will call 9-1-1 so paramedic can come and test her sugar since the meter is only giving her an e-0.

• 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: 7317211
• Report Number: 1000113657-2018-00270
• Device Sequence Number: 151456
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/06/2018

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: MU2625
• 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: 02/09/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1