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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Failure to Power Up (1476); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-25-strip inserted backwards or upside-down.Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure the customer's condition since the initial call and that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact.
Event or Problem Description
Consumer reported complaint for dead meter accompanied by symptom.Meter will not turn on with test strip but pressing the dot button meter came on.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 2/29/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer just purchased the meter over the weekend.

• 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: 8006300
• Report Number: 1000113657-2018-01101
• Device Sequence Number: 428140
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• 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): 10/25/2018

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: MV2909
• 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: 10/02/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1