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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Blurred Vision (2137); Urinary Frequency / Polyuria (2275)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product does not return for evaluation yet.Most likely underlying root cause of malfunction: sample issue.Manufacturer contacted customer with follow up phone calls to know whether the symptoms persist; unable to talk to customer.Product notification letter sent.(b)(4).
Event or Problem Description
Consumer reported complaint for e-5 error, the e-5 is a test strip error, that could means customer may have very high blood glucose result.The e-5 occurred when the blood sample was absorbed.The customer's expected fasting blood glucose test result range is 90 - 120 mg/dl.During the call on (b)(6) 2016, the customer stated that knew the blood sugar levels were high as customer had symptoms of dry mouth, fatigue, thirst, blurred vision and frequent urination.Customer was advised to seek medical attention but declined.During the call on (b)(6) 2016, the customer performed a blood test that produced result of e-5 newly; customer then opened up another box of the same lot number of strips and attempted a retest and received a result of e-5 again.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 02/25/2018 and open vial date is (b)(6) 2016.The meter memory was not reviewed for previous test result history.(b)(6).The customer had not made any recent changes to diet or medication.

• 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: 6141943
• Report Number: 1000113657-2016-01948
• Device Sequence Number: 16412971
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/02/2016

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: 02/25/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1944
• 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: 11/08/2016
• Initial Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY