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

Model Number	TRUEMETRIX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-62-user had poor technique test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure 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 customer care.
Event or Problem Description
Consumer reported complaint for erratic accompanied with symptoms.The expected fasting blood glucose test result range is 85-120mg/dl.The customer did report symptoms of having a rash.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2018, a back to back blood test was performed by the customer and produced test results of 456 and 501mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is one week ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Customer is concerned that readings are erratic and high but doesn't believe they should be this high.

• 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: 7978316
• Report Number: 1000113657-2018-01062
• Device Sequence Number: 1382163
• Product Code: NBW
• UDI-Device Identifier: 00010939719447
• UDI-Public: (01)00010939719447
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/18/2018

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: MU2642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1