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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Weakness (2145)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
((b)(4).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 in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for dead meter.Kinsey is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling weak.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 (b)(6) 2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.The meter is not coming on.Customer is using the proper test strips.The strips are being inserted correctly.The battery has been installed properly with the + sign upwards.A new battery was used and was it properly installed.Customer is feeling weak.Customer will get a replacement meter at the pharmacy.

• 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: 6948914
• Report Number: 1000113657-2017-01803
• Device Sequence Number: 108510
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: MU2381
• 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: 09/20/2017
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1