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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Polydipsia (2604)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-18 user has high glucose value.(b)(4).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 initially reported complaint for e-0: invalid hematocrit.The e-0 error occurred as soon as the blood sample was absorbed.During the call on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of hi and 568 mg/dl using truemetrix meter.The customer is concerned with tests results from results obtained of hi and 568 mg/dl.The customer's expected blood glucose test result range was not provided.At the time of the call, the customer reported feeling tired, fatigued and having increased thirst.The customer declined any medical attention at the time of the call.The product is stored according to specification.The test strip lot manufacturer's expiration date is 08/31/2018 and open vial date is 07/26/2017.The meter memory was reviewed for previous test result history: 568mg/dl, (b)(6) 2017, 12:34:00 pm, fasting: no; hi, (b)(6) 2099, 12:30:00 pm, fasting:no; memory concerns:568 mg/dl, not fasting, hi.

• 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: 6805603
• Report Number: 1000113657-2017-01585
• Device Sequence Number: 1540692
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/18/2017

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 Expiration Date: 08/31/2018
• 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: 07/27/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1