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

Model Number TRUEMETRIX

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dizziness (2194)

Event Date 04/01/2017

Event Type  malfunction  

Manufacturer Narrative

Internal report # (b)(4).Product not returned for evaluation.No replacement needed.Complaint resolved by training.Most likely underlying root cause of malfunction: strip inserted backwards or upside-down test strip udi# (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 Description

Consumer reported complaint for dead meter.Blanca is calling on behalf of the customer.The customer's expected blood glucose test result range was undisclosed.During the call on (b)(6) 2017 the customer was feeling dizzy.During the call on (b)(6) 2017, the meter came on when a test strip was inserted and by manually pressing the button on top of the meter.The battery was installed properly with the + sign upwards.During the call on (b)(6) 2017, a blood test was performed by the customer and produced test result of 186 mg/dl using truemetrix meter.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 01/22/2018 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.Complaint was resolved by training.

• Brand Name: TRUEMETRIX
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 6522483
• MDR Text Key: 73747396
• Report Number: 1000113657-2017-00737
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007690
• UDI-Public: (01)00021292007690
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1888
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 04/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY